NIAIC

Medical Device and Equipment Alerts (MDEA) Updates - 2008

Number	Issue Date	Level Of Urgency	Title
MDEA(NI)2008/092	22 Dec 08	Immediate Action	Oxford disposable slings supplied by Joerns Healthcare / The sling material can tear resulting in the occupant falling out of the sling (PDF 775 KB)
MDEA(NI)2008/91	18 Dec 08	Action	Implantable drug pumps manufactured by Medtronic – SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637. Risk of delays in the resumption of drug infusion and in the logging of motor stall events following MRI scanning (PDF 1.01 MB)
MDEA(NI)2008/090	17 Dec 08	Immediate Action	Anaesthesia kits and epidural filters manufactured by Becton Dickinson (BD). Specific models and lot numbers. Risk of infection as the sterile barrier of the unit pack may be compromised due to holes in the packaging (PDF 285 KB)
MDEA(NI)2008/089	10 Dec 08	Action	IVD point of care test – prostate specific antigen (PSA) manufactured by Innovacon Inc USA, Surescreen and Fortress Diagnostics. Potential for false negative results due to reduced stability (PDF 1 MB)
MDEA(NI)2008/088	9 Dec 08	Immediate Action	PVB arterial pressure monitoring kit. Manufacturer: Codan PVB Critical Care GmbH. Product Code: STP-90R. Due to a manufacturing error, there may be loose tap inserts in these kits. This may result in the stopcock becoming dislodged, leading to arterial bleeding (PDF 167 KB)
MDEA(NI)2008/087	21 Nov 08	Immediate Action	Adult and paediatric manual resuscitators, manufactured by Marshall Products Ltd.Lot numbers L000028, L000088, L080401 to L080419 and L080526 to L080543./ There may be significant difficulty in connecting or disconnecting the device’s 15mm outlet directly onto airway devices such as endotracheal tubes or laryngeal masks (PDF 557 KB)
MDEA(NI)2008/086	21 Nov 08	Action	Tower Fans, Micromark / Risk of fire - Two Trusts have had fire incidents caused by these fans (PDF 254 KB)
MDEA(NI)2008/085	19 Nov 08	Action	LIFEPAK CR Plus automatic external defibrillator manufactured by Medtronic Physio-Control. Various serial numbers. Failure to deliver therapy. A faulty internal cable in defibrillators manufactured between November 2006 and March 2008 means the defibrillator may fail to power on (PDF 247 KB)
MDEA(NI)2008/084	17 Nov 08	Action	Frazier and Poole suction instruments used in surgery / Manufactured by ConMed Corporation / Risk of compromised sterility due to unvalidated method of packaging inspection (PDF 503 KB)
MDEA(NI)2008/083	12 Nov 08	Action	Enteral feeding pump. ClearStar model M771 manufactured by Abbott Nutrition. Specific serial numbers. Risk of under-infusion due to cracking/breaking of an internal adapter bracket. Following an initial service programme of these pumps in 2007 (see MDEA(NI)2007-066), Abbott has identified another 298 pumps that may be affected. Abbott is running a second service programme but is unable to locate 38 of these pumps (serial numbers listed in the appendix) (PDF 328 KB)
MDEA(NI)2008/082	10 Nov 08	Action	Mermaid, Dipper and Ranger bath hoists manufactured by Joerns Healthcare (part of Sunrise Medical Ltd) / Risk of a fall from the hoist resulting in serious injury or death due to lack of safety belt (PDF 121 KB)
MDEA(NI)2008/081	29 Oct 08	Immediate Action	Breezy Moonlite manual wheelchair manufactured by Sunrise Medical. Sudden failure of the backrest hinge can lead to injury of the occupant and/or carer (PDF 128 KB)
MDEA(NI)2008/080	28 Oct 08	Action	Storm3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare.The original tie-down brackets fitted to these wheelchairs are not suitable for the new heavy duty four point webbing tie-down systems manufactured by Unwin Safety Systems Limited (PDF 122 KB)
MDEA(NI)2008/079	24 Oct 2008	Action	Kid Active folding manual wheelchair with swing away footrests manufactured by Lomax Mobility Ltd. Risk of fall and serious injury due to limited forward stability (PDF 129KB)
MDEA(NI)2008/078	23 Oct 08	Action	Savanah 2” and 4” raised toilet seats manufactured by Homecraft Rolyan. The rubber pad on the mounting brackets can become detached. This means the seat cannot be tightened securely to the toilet and may slip when used causing the user to fall and injure themselves (PDF 175KB)
MDEA(NI)2008/077	8 Oct 08	Immediate Action	Solus laryngeal mask airway manufactured by Intersurgical.Product code: 8002, lot no: 380009. Possibility of moulding defects in the device’s 15mm connector, which could cause it to break off during use (PDF 399 KB)
MDEA(NI)2008/076	7 Oct 08	Action	Quickie Groove battery powered wheelchair manufactured by Sunrise Medical / Inadequate instructions when using the wheelchair as a seat in a vehicle (PDF 782 KB)
MDEA(NI)2008/075	7 Oct 08	Action	Alternating air mattress pumps models PHP198,396, 398 and 399 supplied by Park House Healthcare Ltd / Failure of timer mechanisms leading to the loss of pressure relief.(PDF 122 KB)
MDEA(NI)2008/074	7 Oct 08	Action	Access and Accent attendant propelled wheelchairs manufactured by Remploy Healthcare / Rear tie-down location brackets not fitted (PDF 122 KB)
MDEA(NI)2008/073	3/10/08	Action	The risk to water supplies, in sensitive hospital areas, from microbiological water treatment / Failure to remove chemicals, (Silver-stabilised hydrogen peroxide and similar based chemicals), used for microbiological treatment of water supplies can produce a risk of exposure to potentially dangerous chemicals, which can cause severe injury to patients (PDF 124 KB)
MDEA(NI)2008/072	26 Sep 08	Immediate	Histology slide staining automated processors: Benchmark and Discovery manufactured by Ventana Medical Systems Inc / Risk of incorrect staining results, which may lead to misdiagnosis (PDF 1.63MB)
MDEA(NI)2008/71	23 Sept 08	Action	Implantable cardioverter defibrillators – all manufacturers and models / Risk of electric shock to clinicians or mortuary personnel while removing implantable cardioverter defibrillators (ICDs), Risk of explosion during ICD incineration, Need to maintain device/data integrity for ICDs subject to investigation (PDF 123 KB)
MDEA(NI)2008/70	22 Sept 08	Action	Instrumentation for total knee replacement surgery: NexGen Articular Surface Insertion Instrument manufactured by Zimmer Inc (specific lot numbers) / Recall of instruments that do not meet material specifications (135 KB)
MDEA(NI)2008/069	19 Sept 08	Action	Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts (specific product and lot codes – see Appendix). Risk of loosening, excessive wear and fracture of knee replacement components, due to a manufacturing defect (PDF 291 KB)
MDEA(NI)2008/068	11 Sept 08	Action	Neurostimulator programmers manufactured by Medtronic – N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders. An error in the programmer software (revision NNB_01) may lead to false warnings of a low battery status. There is a risk that pre-existing symptoms may return if the device ceases to function when true low or end of service battery warnings are subsequently ignored (PDF 773 KB)
MDEA(NI)2008/067	4 Sept 08	Action	Obturator – Venflon™ IV cannula obturator manufactured by BD. Product code numbers 394252 and 394253. Various lot numbers. Due to a manufacturing problem, there may be cracks and holes in the packaging of the listed obturators for Venflon™ cannulae, which could compromise sterility (PDF 122 KB)
MDEA(NI)2008/066	4 Sept 08	Action & Information	Syringe and Needles. During September 2008 the regional contract for the supply of syringes and needles to HSC will change across Northern Ireland. All syringes and needles supplied under the regional contract will be supplied by Becton Dickinson (BD) Medical. This change will require all syringe pumps used throughout the HSC system to be calibrated in accordance with the manufacturers instructions for use for the syringe type being used (PDF 122 KB)
MDEA(NI)2008/065	13 Aug 08	Information	Sonesta 6210 fluoroscopy procedure table manufactured by Stille / Report of uncontrolled movement of this device caused by a short circuit in the handset. The device has a battery backup and movement cannot be stopped by disconnecting the device from the mains. There is a risk of serious patient injury if this failure occurs during examination with the c-arm (PDF 126 KB)
MDEA(NI)2008/064	05 Aug 08	Immediate	Galemed Corporation / Emergency and transport EMS ventilator circuits, product code W196-002, lot number 20070709, supplied by Smiths Medical / Extension of recall – valve in the breathing system will not open, resulting in a lack of oxygen delivery (PDF 140 KB)
MDEA(NI)2008/063	04 Aug 08	Action	Siemens Healthcare Diagnostics / Laboratory analyser – ADVIA Centaur CP immunoassay system, serial number 086-A001-XX / Dispensing errors using the 10µl probe may have lead to falsely low results for alphafetoprotein (AFP) and myoglobin tests (PDF 470 KB)
MDEA(NI)2008/062	04 Aug 08	Action	Arjo / Carendo multi-purpose hygiene chair / Risk of entrapment of genitalia (PDF 122 KB)
MDEA(NI)2008/061	31 July 08	Immediate Action	Blood glucose meters – Ascensia Contour (5-second) manufactured by Bayer Diabetes Care. Affected devices may show falsely high readings when testing samples from neonates less than 24 hours old. This may mask hypoglycaemia (PDF 159 KB)
MDEA(NI)2008/060	30 July 08	Action	Medi-Tec Classic hoist manufactured by Aidservice Ltd. Risk of spreader bar becoming detached in use and dropping the hoist occupant.(PDF 78 KB)
MDEA(NI)2008/059	25 Jul 08	Immediate Action	Laboratory analysers and their associated assays – ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems, manufactured by Siemens Healthcare Diagnostics, serial numbers 078-A001-XX and XP 078-A010-XX. Failure to detect a low level of wash 1 fluid. This may lead to erroneous test results in high risk biomarkers (PDF 465 KB)
MDEA(NI)2008/058	23 Jul 08	Action	Smiths Medical Portex™ Blue Line Ultra tracheostomy kits, lot no. 499265. Blue Line Ultra Suctionaid tracheostomy change kits (product code 100/880/080) from lot 499265 will contain a Blue Line Ultra fenestrated, uncuffed tube. Although this tube will maintain an airway if used, it will reduce ventilation efficiency and will not provide any direct suctioning ability. Smiths Medical is recalling these devices due to the incorrect labelling (see appendix) (PDF 199 KB)
MDEA(NI)2008/057	22 Jul 08	Action	Unomedical OP suction tubing lot 182281 only. Product code 16172182. Due to a manufacturing error there is the potential for the tubing to collapse whilst in use, preventing suction (PDF 121 KB)
MDEA(NI)2008/056	21 Jul 08	Action	Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare. Some variants of the Puma and Beatle are too heavy for standard four point webbing tie-down systems for use in a vehicle (PDF 169 KB)
MDEA(NI)2008/055	21 Jul 08	Immediate Action	Kimal safety fistula needle (all product codes and lots). Kimal is aware of the potential for the unintentional retraction of the cannula into the protection sheath, which can result in exsanguination. As a result, Kimal is recalling all lots of the device (PDF 128 KB)
MDEA(NI)2008/054	08 Jul 08	Action	Harrier Heavy Duty (HD) battery powered wheelchair manufactured by Invacare / These wheelchairs have been supplied without battery transportation straps. This means there is the potential for the battery to detach from the frame in the event of a vehicle impact. Additionally, changes have also been made to the instructions for use with regard to the wheelchairs use as a seat in a vehicle (PDF 122 KB)
MDEA(NI)2008/053	04 Jul 08	Action	Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe pumps / Possibility of patients being given an additional/unnecessary infusion when syringes are changed or infusions restarted when using DrugPro software (PDF 130 KB)
MDEA(NI)2008/052	03 Jul 08	Action	BabyCare crib trolleys with drop-shelves, manufactured by Huntleigh Healthcare and Hoskins Medical Equipment / The drop-shelves fitted to these crib trolleys may collapse under the weight of a baby bath and should not be used for this purpose (PDF 125 KB)
MDEA(NI)2008/051	03 Jul 08	Action	Procedure packs from various manufacturers which contain BD Medical Surgical Systems 2ml, 5ml and 10ml Plastipak Luer slip syringes / Potential for the BD Luer slip syringes supplied in procedure packs to spontaneously disconnect or fail to maintain a secure connection to Luer fittings of other devices (PDF 126 KB)
MDEA(NI)2008/050	03 Jul 08	Action	Lancing devices (used in pharmacy settings) – all brands / Risk of transmission of blood borne infections between patients if a lancing device is used for multiple patient testing, contrary to the manufacturer's instructions for use (PDF 126 KB)
MDEA(NI)2008/049	01 Jul 08	Immediate	Gambro and Hospal blood sets (lot numbers 0806 – 0817) / Gambro has identified the potential for a total or partial occlusion of the arterial (red) and/or venous (blue) dialyser connectors of these blood tubing sets. This is due to a moulding defect (PDF 196 KB)
MDEA(NI)2008/048	26 June 08	Action	Action³ manual wheelchair with fixed back and height adjustable push handles manufactured by Invacare / Fixed backrests on Action³ wheelchairs fitted with height adjustable push handles have fractured in use, placing the occupant and carer at risk of injury (PDF 183 KB)
MDEA(NI)2008/047	25 June 08	Immediate	Pregnancy test kits– Clinitest hCG Cassette, lot numbers 97552 and 97574 (professional use only), manufactured by Siemens Healthcare Diagnostics / Recall due to the potential for false negative results (PDF 327 KB)
MDEA(NI)2008/046	18 June 08	Immediate	FocalSim radiotherapy treatment planning software manufactured by Computerized Medical Systems Inc. FocalSim software versions 4.3.1 to 4.34.02 inclusive / Potential for miscalculation and incorrect display of patient doses leading to over-exposure and/or unnecessary exposure(s) to radiation (PDF 128 KB)
MDEA(NI)2008/045	17 June 08	Action	Chest drain: Thoraseal II chest drainage unit manufactured by Covidien, formerly Tyco Healthcare / Inadvertent disconnection of the drainage tubing from the bottle (PDF 147 KB)
MDEA(NI)2008/044	17 June 08	Action	Electrosurgical single-use, sterile blades and needles.‘Universal’ and ‘Ultraclean’ electrodes manufactured by ConMed / A limited number of electrosurgical blades and needles may have an inadequate packaging seal, potentially compromising the sterility of the device (PDF 218 KB)
MDEA(NI)2008/043	17 June 08	Action	Medtronic Physio-Control LIFEPAK® 12, LIFEPAK® 20 and LIFEPAK® 20e external defibrillators with certain settings - When used in AED mode with ‘Auto Analyze’ ON, the ECG analysis (Shock Advisory System™) may start before a warning is given to the user to stand clear of the patient. This can result in inappropriate shock or no shock recommendations being made by the device due to CPR or movement artefacts(PDF 192KB)
MDEA(NI)2008/042	9 June 2008	Action	All manufacturers / Implantable drug pumps for intrathecal therapy / Risk of temporary or permanent neurological impairment due to inflammatory or granulomatous mass formation at the catheter tip (PDF 123 KB)
MDEA(NI)2008/041	9 June 2008	Action	All posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs / Use of an inappropriate type of, or incorrectly fitted or adjusted posture/safety belt can lead to death or serious injury of the occupant (PDF 152 KB)
MDEA(NI)2008/040	4 June 08	Action	Smiths Medical / Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush device. Manufactured from October 2007 to February 2008 inclusive / A fault in the manufacture of the trigger flush device can lead to over-infusion of fluid and falsely elevated blood pressure measurements (PDF 100 KB)
MDEA(NI)2008/039	30 May 08	Action	Duvet covers and other soft furnishings / risk of self harm (PDF 47 KB)
MDEA(NI)2008/038	28 May 08	Action	Battery powered wheelchairs, Storm and Storm True Track (TT) Manufactured by Invacare.The Storm TT wheelchair and some variants of the Storm are too heavy for any standard four point webbing tie-down system commercially available for use in a vehicle (PDF 122 KB)
MDEA(NI)2008/037	23 May 08	Action	Lotus Professional compact toilet roll holder/dispenser: risk of ligature source (PDF 18 KB)
MDEA(NI)2008/036	23 May 08	Action	Patient weigh scales. Potential for medication errors due to incorrectly calibrated or type of weigh scales, giving inaccurate readings or inappropriate scales being used (PDF 597 KB)
MDEA(NI)2008/035	22 May 08	Immediate Action & Update	Fluid warming sets. Level 1® normothermic IV fluid administration and irrigation sets - D/DI and IR/IRI series manufactured by Smiths Medical; Some sets have small holes in the inner lumen (aluminium tube) that allow contamination of the infusate with the heating fluid. Following the MDEA issued in August 2007, the manufacturer is now in a position to recall and replace all affected stock (PDF 130 KB)
MDEA(NI)2008/034	20 May 08	Action	Masimo Rainbow Rad-57 Pulse CO-Oximeter / Elevated levels of methaemoglobin (MetHb) will lead to inaccurate carboxyhaemoglobin (COHb) readings (SpCO) and Elevated levels of either MetHb or COHb will lead to inaccurate oxygen saturation readings (SpO2) (PDF 121 KB)
MDEA(NI)2008/033	14 May 08	Immediate Action	Robertshaw endobronchial tubes (PVC, disposable) all sizes – manufactured by Phoenix Medical, a P3 Medical Ltd company. There is a risk of plastic debris from the intubating stylet entering the patient’s airway due to a manufacturing defect (PDF 128KB)
MDEA(NI)2008/032	30 April 08	Action	Walking frames for adults and children manufactured by Trulife Limited: The plastic height adjustment clips can fail, causing the user to fall (PDF 183 KB)
MDEA(NI)2008/031	30 April 08	Action	Surgical blades manufactured by ConMed Linvatec Hall: Possibility of holes in the packaging which may compromise sterility (PDF 481 KB)
MDEA(NI)2008/030	21 April 08	Action	Beatle and Puma battery powered wheelchairs manufactured by Movingpeople.net or Handicare. Beatle wheelchairs in front wheel drive (FWD) configuration have tipped when travelling on slopes (PDF 148 KB)
MDEA(NI)2008/029	21 April 08	Action	Disposable pen torch manufactured by Merlin Medical Limited and distributed by Williams Medical Supplies. Model Number: W2137. Incorrect bulb placement due to a manufacturing fault which can cause the bulb to explode upon illumination or be damaged during normal use (PDF 137 KB)
MDEA(NI)2008/028	17 April 08	Immediate Action	Well-Shin WS-023 power lead adapters originally supplied by Pegasus Ltd with Eleganza and Praktika hospital beds and Homecare and Vitalia community beds: Risk of electrocution to patients, bed occupants, staff and others (PDF 185 KB)
MDEA(NI)2008/027	17 April 08	Immediate Action	Birthright birthing bed mattresses manufactured by Huntleigh Healthcare: A risk of cross-infection from contaminated mattress cores (PDF 128 KB)
MDEA(NI)2008/026	14 April 08	Action	ConMed Corporation / Frazier and Poole suction instruments used in surgery / The sterility of some Frazier and Poole suction instruments may be compromised due to inadequate sealing of their packaging (PDF 831 KB)
MDEA(NI)2008/025	7 April 08	Immediate	Smiths Medical / Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush device. Manufactured from October 2007 to February 2008 inclusive / An error in the manufacture of the trigger flush device can lead to over-infusion of fluid (PDF 129 KB)
MDEA(NI)2008/024	7 April 08	Immediate	Hospira UK Ltd / Hospira butterfly winged needle infusion set – regular and intermittent. All batches manufactured prior to April 2008 / Leakage of fluid during IV administration (PDF 129 KB)
MDEA(NI)2008/023	1 April 08	Immediate	Pyramed Limited / ALN retrievable inferior vena cava (IVC) filter / Increased risk of filter migration (PDF 129 KB)
MDEA(NI)2008/022	27 Mar 08	Action	Hospital beds Eleganza Standard, Smart and Deluxe models supplied by Pegasus: The emergency backrest release function on these beds may fail or become stiff and difficult to operate leading to a risk of delay in performing CPR (PDF 186 KB)
MDEA(NI)2008/021	27 Mar 08	Action	Nursing beds. Models 3010 and 5020 manufactured by Volker: Risk of asphyxiation or injury from entrapment of head, neck or chest in the bed rail’s gaps (PDF 121 KB)
MDEA(NI)2008/020	27 Mar 08	Action	Folding shower seat 2000 Series manufactured by AKW Medi-Care Limited.The shower seat supports can fail causing the user to fall.(PDF 122 KB)
MDEA(NI)2008/019	26 Mar 08	Action	Patient turner, model 411973300, manufactured by Etac. Risk of head entrapment in the gap of the handle assembly (PDF 216 KB)
MDEA(NI)2008/018	18 Mar 08	Immediate Action	This alert has been superseded by MDA/2012/020.
MDEA(NI)2008/017	18 Mar 08	Action	Needle free intravascular connectors. all brands: There is a risk of infection if the top/septum of the connector remains recessed within its housing. Swabbing of the connector in this condition may lead to inadequate decontamination (PDF 123 KB)
MDEA(NI)2008/016	18 Mar 08	Action	Patient transfoer slides/boards, models LOCO-400A Duo and LOCO-401A Duo manufactured by Select Healthcare(UK)Ltd: Transfer slides/boards are cracking and breaking (PDF 180 KB
MDEA(NI)2008/015	18 Mar 08	Action	Typhoon and Typhonn 11 battery powered wheelchairs manufactured by Invacare: The wheelchair is too heavy for any standard four point webbing tie-down system commercially available for use in a vehicle (PDF 122 KB)
MDEA(NI) 2008/14	10 Mar 08	Action	Medical air plant: risks associated with critical component failure. Two incidents have been reported involving failure of 4-bar medical air plant due to a fault in the central control unit (CCU) printed circuit board (PCB) and motor control unit (MCU) PCB with fuses. This resulted in the loss of all three medical air compressors for over 24 hours, requiring the hospital to use the emergency reserve manifold (ERM) and secure sufficient replacement medical air cylinders to meet demand (PDF 121 KB)
MDEA(NI) 2008/13	10 Mar 08	Action	Heel & Elbow and Heel & Ankle Gelbodies used to help prevent pressure ulcers. Manufactured by Trulife: Risk of broken skin, friction burns, and redness from using Heel & Elbow and Heel & Ankle Gelbodies over a period of prolonged continuous use (PDF 121 KB)
MDEA(NI) 2008/12	5 Mar 08	Immediate Action	Medication cassette reservoir for CADD® Legacy and CADD® Prizm infusion pumps manufactured by Smiths Medical Model numbers 21-7001-24, 21-7002-24 and 21-7100-24. Lot numbers 023X17 to 122X17 inclusive: Manufacturing fault that may allow leakage from, or entry of air into, specific lot numbers of medication cassette reservoir (PDF 159 KB)
MDEA(NI)2008/11	3 Mar 08	Action	Automated peritoneal dialysis systems. Homechoice/Homechoice Pro (Baxter Healthcare Ltd). A potential for the unrecorded delivery of infused fluid during treatment (PDF 191 KB)
MDEA(NI)2008/10	3 Mar 08	Action	Ambulift hoist. All models manufactured by Arjo or Mechanaids: Risk of the occupant slipping from the seat during use (PDF 120 KB )
MDEA(NI)2008/009	27 Feb 08	Immediate Action	Blood coagulation test. SmartCheck INR system manufactured by Unipath Ltd: Risk of inaccurate results leading to incorrect dosing of anticoagulant therapy (PDF 602 KB)
MDEA(NI)2008/008	22 Feb 08	Action & Information	Hospital beds. Hill-Rom Avantguard 1200 and 1400 with manually operated lock-out function: Lack of use of the manual lock-out function has lead to fatalities from crush injuries (PDF 121 KB)
MDEA(NI)2008/007	14 Feb 08	Immediate Action	Stretchers/trolleys manufactured by Stryker Medical: The brake mechanism used on some models may not lock due to a component failure or excessive wear (PDF 323 KB)
MDEA(NI)2008/006	13 Feb 08	Action	Blood glucose meters and test strips:MediSense Optium, Optium Xceed meters manufactured by Abbott Diabetes Care; Boots brand meters; and OneTouch Ultra test strips manufactured by LifeScan: The OneTouch Ultra test strips may generate incorrect results when used in conjunction with the MediSense Optium, Optium Xceed or Boots brand meters (PDF 124 KB)
MDEA(NI)2008/005	13 Feb 08	Action	Hard-shell venous reservoirs and oxygenators used for cardiopulmonary bypass during heart surgery: various manufacturers: A bolus of air was forced up the venous line to the heart when a quick-prime line was misconnected to the vent port of a hard-shell venous reservoir.A problem with a vaporiser prevented the oxygen supply reaching the oxygenator (PDF 121 KB)
MDEA(NI)2008/004	31 Jan 08	Action & Update	Umbilical cord clamp clipper manufactured by Unomedical Ltd. Product reference 84006182 - affected lot number 163136: there is the potential for the blade to fall out of this device or break during use. This is an expansion of a recall previously carried out in November 2006 and referred to in MDEA(NI)2007/036 (PDF 129 KB)
MDEA(NI)2008-003	17/1/08	Immediate	Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd - Total knee replacement implants -VKS, RT- Plus and TC- Plus femoral and tibial knee components / Extension of recall of implants which may have incorrect alloy composition (PDF 914 KB)
MDEA(NI)2008-002	17/1/08	Action	Huntleigh Healthcare Birthright and Hoskins Birthcare / Birthing Beds - these beds can become unstable and tip if patients, visitors or staff sit or kneel near the foot end of the bed ( PDF 122 KB)
MDEA(NI)2008-001	4/1/08	Action	Medical devices; non-medical equipment, plant and buildings / Under-reporting of medical device and estates related adverse incidents to the NorthernIreland Adverse Incident Centre (PDF 123 KB)