NIAIC

Medical Device and Equipment Alerts (MDEA) Updates - 2006

Number	Issue Date	Level Of Urgency	Title
MDEA(NI)2006/81	21 Dec 06	Action	Electrically Operated Beds: Risk of Physical Damage to Adjacent Building Services - The Rise and Fall Action Of Profiling Beds can Accidentally Damage Electrical Power Plugs and Sockets and Other Fixed Services (PDF 140 KB)
MDEA(NI)2006/80	21 Dec 06	Immediate	Quattrocare Spray Cans For Use in KAVO Quattrocare Dental Handpiece Maintenance System - Risk of Explosion - Can May Leak Flammable Gas When Attached to the Quattrocare Device (PDF 616 KB)
MDEA(NI)2006/79	20 Dec 06	Immediate Action	Counterfeit Condoms: DUREX FETHERLITE 3 PACK - LOT 21405074, DUREX PERFORMA 3 PACK - LOT TGL4142, DUREX GASSAMER 3 PACK - LOT 21405074: Counterfeit DUREX Condoms Have Been Placed on the Open Market (PDF 145 KB)
MDEA(NI)2006/78	19 Dec 06	Action	Radial Artery Introducer Sets: Wiliam Cook Europe Flexor Check-Flo Micropuncture Radial Artery Access Introducer Sets With AQ Hydrophilic Coating - Manufacturer Has Received Reports of Inflammatory Responses at the Access Site of a Number of Patients Following Use of This Device (PDF 161 KB)
MDEA(NI)2006/77	18 Dec 06	Immediate	LIFESACN ONETOUCH ULTRA, LIFESCAN INDUO AND LIFESCAN POCKETSCAN Blood Glucose Meters - The Units of Measurement Displayed May Change From MMOL/L to MG/DL, Resulting In the User Thinking That the Blood Glucose Level is Too High and Thus Altering the Treatment Regime Inappropriately (PDF 165 KB)
MDEA(NI)2006/76	18 Dec 06	Action	Wash Set Bowls Used in SORIN Group DIDECO Electa and Compact Autotransfusion Machines - Due to Manufacturing Problems Producing Misshapen Bowls, There Have Been Reports of Difficulties With the Insertion of The Wash Set Bowl, Which Can Result in Black Particles Being Deposited Inside The Wash Bowl During Use (PDF 167 KB).
MDEA(NI)2006/75	18 Dec 06	Immediate	PHYSIOLOGICAL MONITOR: SMITHS MEDICAL 3404 BCI AUTOCORR Plus Pulse Oximeter/ECG/Respiration Monitor - Noisy or No Display of SpO2, ECG or Respiration Readings Due to Faulty Component in a Known Group of Devices (PDF 171 KB)
MDEA(NI)2006/74	14 Dec 06	Action	Huntleigh Healthcare Contoura 880 Hospital Beds: Failure of Bed Safety Rails (PDF 272 KB)
MDEA(NI)2006/73	7 Dec 06	Action	CORY BROTHERS LTD:SUCTION TUBING - MODEL NUMBER:MPC CST/50/6, BATCH NUMBER:0606120, BOXNUMBERS 189 TO 252 INCLUSIVE - splitting along the black line can occur because of a manufacturing error leading to a loss of suction. specific boxes have been recalled (PDF 145 KB)
MDEA(NI)2006/72	7 Dec 06	Immediate	Lancing devices used in Nursing Homes and Care Homes - Transmission of HEPATITIS B between Nursing Home Residents (PDF 1940 KB)
MDEA(NI)2006-71	24 Nov 06	Action	St Jude Medical pacemakers: Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376. St Jude Medical programmers:APS III model 3500, APS III model 3510 and Merlin PCS model 3650 (PDF 1165 KB) Potential for inaccurate display of: battery voltage expected battery longevity Elective Replacement Indicator (ERI) status at initial programmer interrogation.
MDEA(NI)2006-70	21-Nov-06	Action	ANSELL(UK) LTD - Micro-Touch Ultra PF powder free latex examination gloves / recall of specific lot numbers. Some gloves may be subject to premature aging (PDF 302 KB)
MDEA(NI)2006-69	17 Nov 06	Immediate Action	EATON ELECTRICAL LTD(MEM and BILL - Electrical Distribution Switchgear, 160A AND 200/250A FCS switches/fuse switches : operation failure: circuit was still live when switch in off position (PDF 528 KB)
MDEA(NI)2006-68	31 Oct 06	Action	Counterfeit Condoms: DUREX Extra Safe 3 pack - LOT 20604354: counterfeit DUREX Condoms have been placed on the UK Market (PDF 166 KB)
MDEA(NI)2006-67	31 Oct 06	Action & Update	Doors as Ligature Points: Risk of fatality from the use of a door/window opening as ligature anchor point (PDF 143 KB)
MDEA(NI)2006-66	27 Oct 06	Action	SENDAL SA Distributed by Arcomedical Infustion Ltd Blood Administration Set: Volumed Blood Set : Risk of blood leakage due to crack at the Y site on a single batch of the blood set (PDF 143 KB) .
MDEA(NI)2006-65	27 Oct 06	Action	URINE BAG: COLOPLAST CONVEEN URINE BAG 1500ml, 90cm tube , non sterile: failure to drain urine due to blocked non-return valve. The manufacturer is recalling specific batches of the device (PDF 144 KB)
MDEA(NI)2006-64	20 Oct 06	Immediate Action	Waste Compactor: Risk of Death (PDF 144 KB)
MDEA(NI)2006-63	19 Oct 06	Action	SUNRISE MEDICAL JAY J2: WHEELCHAIR BACKS: the manufactures original instructions for use (IFU) did not give sufficient detail to allow the devices to be fitted, used and maintained safely, thus putting the users of the backs at risk of serious injury (PDF 821 KB)
MDEA(NI)2006-62	18 Oct 06	Action	TECN VAP Model: Junior Star - Steam cleaner/vacuum cleaner: Electrical tracking across mating surfaces of the Euro interconnecting plug (PDF 288 KB).
MDEA(NI)2006-61	13 Oct 06	Immediate Action	JENX LIMITED: SEATING SUPPORT SYSTEMS FOR CHILDREN: Manufactures Original Instructions For Use (IFU) do not give sufficient guidance on how to correctly set up the complete seating support system, adjust it and maintain adjustment during use, thus putting users at risk of death or serious injury (PDF 153 KB).
MDEA(NI)2006-60	4 Oct 06	Action	HUNTLEIGH HEALTHCARE BIRTHRIGHT AND HOSKINS BIRTHCARE - BIRTHING BEDS -beds can become unstable and tip if patients, visitors or staff sit on the foot end of an unoccupied bed (PDF 210 KB).
MDEA(N()2006-59	4 Oct 06	Action	PHYSIOTHERAPY ULTRASOUND MACHINES: Calibration of acoustic power/intensity - following testing acoustic powers and intensities were found to be different from those expected. This relates directly to the efficacy and safety of patient treatment (PDF 145 KB).
MDEA(NI)2006-58	29 Sept 06	Action	SUNRISE MEDICAL JAY J2: WHEELCHAIR BACKS: The Manufactures Original Instructions For Use (IFU) did not give sufficient detail to allow the devices to be fitted, used and maintained safely, Thus putting the users of the backs at risk of serious injury (PDF 487 KB)
MDEA(NI)2006-57	22 Sept 06	Action	MAXILLOFACIAL Surgery Drills - handpieces used with oral - lack of appropriate maintenance leading to overheating and oral burns (PDF 144 KB)
MDEA(NI)2006-56	19 Sept 06	Immediate	LIFESCAN ONETOUCH ULTRA 2 - Blood Glucose Meters - Recall because of potential to misread results (PDF 321 KB)
MDEA(NI)2006-55	19 Sept 06	Action	LASSMEDTRONIC: MIDAS REX, CIC, GS AND LEGEND - surgical dissecting tools - degradation of sterile packaging.. Recall of devices distributed within the last three years (PDF 253 KB)
MDEA(NI)2006-54	14 Sep 06	Action & Update	Edwards Lifesciences Aquarius Haemofiltration machines: Rupturing of the pre-filter pressure dome (on tubing set) resulting in release of blood at high pressure (PDF 145 KB)
MDEA(NI)2006-53	8 Sep 06	Action & Update	APC MEDICAL LTD : external/temporary cardiac pacemakers model 4170: not all model 4170 external pacemakers have been returned to the manufacturer for modification to prevent unintentional shutdown (PDF 145 KB)
MDEA(NI)2006-52	24 Aug 06	Action	Chest Drain: Rocket Medical Seldinger Chest Drainage Set, 12FG Model Code R54544-12-00: Risk of Pneumothorax due to the possible detachment of the Leur fitting and catheter during use (PDF 238 KB)
MDEA(NI)2006-51	24 Aug 06	Action	Elastomeric infusion pump: Baxter Intermate and Infusor Large Volume (LV) infusion pumps - all models: There is an increased risk of the elastomeric balloon bursting during infusion (PDF 417 KB)
MDEA(NI)2006-50	23 Aug 06	Immidate Action & Information Request	Orthopedic Implants manufactured by Proconcept SA France: CIFEC cervical cages;LIFEC lumbar cages; ALIFEC lumbar cages: SRE/SEO spinal screw systems;CANALETTO carpal tunnel protection implants: Invalid CE certification; deficiencies in technical documentation, production and traceability (PDF 143 KB)
MDEA(NI)2006-49	10 Aug 06	Action	Anaesthetic Conserving Device:Sedana Medical Anaconda (PDF 143 KB)
MDEA(NI)2006-48	7 Aug 06	Action	AFOS LTD - Endoscope Storage Facility (ESF) -Safety Chain From Top Cupboard of ESF Cabinets May Be Missing, This Can Lead to Door Dropping and Causing Injury (PDF 160 KB)
MDEA(NI)2006-47	7 Aug 06	Action	BECTON DICKINSON VACUTAINER DIRECT DRAW ADAPTOR Product Code 364896 and VACUTAINER LUER ADAPTOR Product Code 367300 - Risk of Blood Leakage During Blood Collection at the Non-Patient End of the Adaptor (PDF 199 KB)
MDEA(NI)2006-46	26 July 06	Immediate Action	Shower Head / Potential LIigature Point (PDF 165 KB)
MDEA(NI)2006-45	26 July 06	Action	CARDINAL HEALTH / SYRINGE PUMP IVAC P4000 / Remote possibility that displayed low flow rate may spontaneously change its format from Tens, Units and Tenths to Hundreds, Tens and Units (PDF 188 KB).
MDEA(NI)2006-44	20 July 06	Action	Devices in cardiac catheterisation and interventional radiology laboratories, including devices suspended from the ceiling: reports of adverse incidents where devices have not been maintained, leading to the failure of the device (PDF 141 KB).
MDEA(NI)2006-43	20 July 06	Immediate Action	Cardiac atrial septal occluder - Amplatser, AGA Medical: Haemodynamic compromise associated with incorrectly sized occluder (PDF 397 KB)
MDEA(NI)2006-42	19 July 06	Action	Medical Gas Cylinders and Regulators : Risk of fire/explosion due to contamination with hand creams, moisturisers, grease etc (PDF 142 KB)
MDEA(NI)2006-41	19 July 06	Action	Various devices in cardiac catheterisation and interventional radiology laboratories, especially the x-ray c-arm: devices have been damaged by collision with the x-ray c-arm but have remained in use and subsequently failed, causing injury (PDF 141 KB)
MDEA(NI)2006 40	18 July 06	Action	Schneider Electric Limited- RCBOs: Merlin Gerin C60, C60X, Square D KQE, SQOR, QOE: Malfunction of earth leakage fault detection and trip (PDF 321 KB)
MDEA(NI)2006-39	18 July 06	Action & Update	Use of Reusable Pen Injection Devices by Healthcare Workers: Risk of Needlestick Injury (PDF 141 KB)
MDEA(NI)2006-38	17 July 06	Immediate Action & Update	Guidant Implantable pacemaker and implantable defibrillators families: Insignia, Nexus, Contak Renewal TR, Contak Renewal TR2, Ventak Prizm 2 Vitality, Vitality 2; Recall due to component failure (PDF 235 KB) Affected Serial Numbers (PDF 61 KB)
MDEA(NI)2006-37	17 July 06	Action	Blood Pressure Monitors and Sphygmomanometers: Problems experienced by many users in obtaining accurate blood pressure measurements (PDF 640 KB) Measuring Blood Pressure Top ten Tips (PDF 415 KB)
MDEA(NI)2006-36	28 June 06	Action	Electrically Powered Indoor Wheelchairs (EPICs) - Designed For Indoor Use Are Being Used Outdoors And/Or As Seats In Vehicles Putting Occupants At Risk (PDF 146 KB).
MDEA(NI)2006-35	09 June 06	Immediate Action & Update	Freestyle, Freestyle Mini and MediSense Optium Xceed blood glucose meters manufactured by Abbott Diabetes Care (PDF 158 KB) The units of measurement displayed on the blood glucose meter may change from mmol/L to mg/dL, resulting in the meter thinking that the blood glucose level is too high.
MDEA(NI)2006-34	07 June 06	Action	Fischer Cone Biopsy Excisor (FCBE): Apple Medical Corp - Reports of Device Tips Burning and Melting During Use (PDF 199 KB).
MDEA(NI)2006-33	02 June 06	Action	Adult Proctoscopes: SEWARD THACKRAY. Jagged Imperfections may be present on the leading edge of some proctoscopes, adjacent to the obturator, which could injure the patient (PDF 168 KB)
MDEA(NI)2006-32	01 June 06	Action	BAUSCH & LOMB - Contact Lens Solution:Renu with Moistureloc - product is associated with an increased incidence of Fusarium (fungal) Keratitis (PDF 226 KB)
MDEA(NI)2006-31	25 May 06	Action	Electrosurgical vessel-sealing instruments: Valleylab Ligasure Atlas catalogue numbers LS1100 and LS1120. The vessel-sealing cycle may be interrupted during surgery, which could result in incomplete sealing of the blood vessels thereby posing a hazard to the patient (PDF 142 KB)
MDEA(NI)2006-30	24 May 06	Action	Draeger Anaesthetic Vaporisere:Vapor 2000 And D-Vapor / Damage To Nibs On The Colour Coded Plastic Control Dial Can Compromise The Interlock Safety System (PDF 182 KB) Vapor 2000 Operators Manual (PDF 2687 KB)
MDEA(NI)2006-29	17 May 06	Immediate	SLE Ltd single-use heated patient breathing circuits (model numbers beginning with N2188 and N5188)/recall of specific batches due to a manufacturing defect (PDF 224 KB)
MDEA(NI)2006-28	05 May 06	Immediate	Ambulatory insulin infusion pump set, Roche Diagnostics ACCU-CHEK FlexLink: The tubing can fully or partially separate at the leur lock-tubing connection, with the potential for insulin leakage leading to hyperglycaemia (PDF 534 KB)
MDEA(NI)2006-27	04 May 06	Immediate Action & Update	Universal Hospital Supplies Guedal airways - Lot numbers beginning with the year of manufacture e.g 2005 B 11.(Lot numbers with the profix WO are not affected): The supplier is recalling affected lot numbers of Universal Guedal Airways 1, 2, 3 and 4. This is an update to MDEA(NI)2006/24 - identifying additional sizes of the product (PDF 426 KB)
MDEA(NI)2006-26	28 April 06	Immediate Action & Update	Gambro Prisma haemodialysis sets:M60 Pre Set, M60 Set, M100 Pre Set, HF1000 Pre Set Manufactured before the end of October 2005. During disconnection of the Prisma set from the haemodialysis system, blood can leak (under pressure) from the access pressure pod due to a manufacturing defect (PDF 170 KB).
MDEA(NI)2006-25	13 April 06	Action	Baxter Clearlink Needle-free Connector/Valve For Vascular Access:The Instructions For Use Have Undergone Significant Changes, In Particular The.Maximum Period Of The Use Of The Device (PDF 436 KB)
MDEA(NI)2006-24	28 Mar 06	Action	Universal Hospital Supplies Guedel Oropharyngeal Airways, Sizes 2 And 3 - May Be Split Or Partially Occluded, Potentially Causing A Delay During Resuscition (PDF 179 KB).
MDEA(NI)2006/23	23 Mar 06	Action	Baxter Minicap Peritoneal Dialysis Disconnect Cap With Povidone-Iodine - The Povidone-Iodine In The Disconnect Caps Has The Potential To Be a Contributing Factor to Thyroid Changes (PDF 534 KB)
MDEA(NI)2006-22	20 Mar 06	Action	Baxter Haemodialysis Instruments: System 1000 tina, Aurora And Arena - Risk Of Air Entrapment When The Tubing Is Not Correctly Centred In The Venous Line Clamp (PDF 651 KB).
MDEA(NI)2006-21	20 Mar 06	Action	Evab Mark 1 Compact Delivery Bed (obstetric table/birthing Bed) - Risk Of Collapse Due To Fracturing Of Pivot Pins (PDF 142 KB)
MDEA(NI)2006 20	15 Mar 06	Action	Conmed Goldline Single Use Electrosurgical Pencils:Risk of fire and patient/staff burns (PDF 151 KB)
MDEA(NI)2006 19	13 Mar 06	Immediate Action	This alert has been replaced by MDEA(NI)2006/35.
MDEA(NI)2006 18	10 Mar 06	Immediate Action	Portex Spinal/Epidural Needle Set (PDF 152 KB) Product Codes: 100/396/318, 100/396/716, 100/396/718, 100/396/916: A small number of pouches within defined lot numbers have been found to have inadequate seals (PDF 152 KB).
MDEA(NI)2006 17	10 Mar 06	Action	Medical Gas Flexible hoses within pendants - Can fail resulting in the loss of gas supply if they are not inspected and replaced at regular intervals (PDF 387 KB)
MDEA(NI)2006 16	10 Mar 06	Action	Smyth & Nephew OpSite Post-Op dressings - Recall of a single batch of 640 units of their OpSite Post-Op dressings because of some reports of open/partially sealed primary pouches giving rise to a risk of infection (PDF 138 KB)
MDEA(NI)2006 15	01 Mar 06	Action	Boston Scientific urological stone retrieval basket(1.9 Fr Zero Tip nitinol), catalogue numbers M0063901040 and M0063901050: Potential for basket wire assembly to detach from wire during insertion procedure (PDF 140 KB).
MDEA(NI)2006 14	24 Feb 06	Action	Hospital bed: Hill-Rom Evolution 150BO. Failure of the bed to quickly achieve the cardio-pulmonary resuscitation (CPR) position using the manual control mechanism (PDF 136 KB).
MDEA(NI)2006 13	23 Feb 06	Action	William Cook Europe ApS/Tiger tube nasojejunal feeding tube-product code C-NJFT-14F/recall of all batches (PDF 143 KB)
MDEA(NI)2006 12	23 Feb 06	Action	Baxter Ipump pain management system. APII infusion pump.PCAII syringe infusion pump / three problems with pump (PDF 172 KB)
MDEA(NI)2006 11	20 Feb 06	Immediate Action	Baxter Colleague Volumetric Infusion Pumps: All Models (PDF 1.57 Mb) There are three problems that can cause the pump to stop and alarm resulting in an interruption to therapy. There are two further issues with no accompanying alarms. All these problems present risk of death or serious injury
MDEA(NI)2006 10	09 Feb 06	Immediate Action	Intersurgical Clear-Therm heat and moisture exchanging filter(HMEF) with Leur lock port and retainable cap (check model and batch number): The Leur Lock (used for connection to CO2 monitoring) may be occluded by plastic (PDF 143 KB)
MDEA(NI)2006 09	09 Feb 06	Action	The Medical House mhi-500 Insulin Jet needle free insulin delivery system: Risk of device fracture which may cause harm to the operator (PDF 265 KB)
MDEA(NI)2006 08	07 Feb 06	Immediate Action & Update	Guidant Implantable Pacemaker Models: Pulsar, Pulsar MAX, Pulsar MAX II, Discovery, Discovery II, Meridian, Contak TR. (PDF 198 KB) Affected Serial Numbers (PDF 67 KB)
MDEA(NI)2006 07	06 Feb 06	Immediate Action	BOC Ltd, CD and HX Oxygen Cylinders with Faulty Pressure Gauges. (PDF 197 KB)
MDEA(NI)2006 06	01 Feb 06	Action	Optical Smoke Detectors - Potential Failure to Operate (PDF 139 KB)
MDEA(NI)2006 05	24 Jan 06	Action	Crest Medical Blue Dot umbilical cord clamps and Crest Medical maternity packs (PDF 140 KB)
MDEA(NI)2006 04	19 Jan 06	Action	Automatic sliding doors: Risk of canopy falling: The canopy on some automatic doors could fall if accidentally knocked (PDF 349 KB)
MDEA(NI)2006 03	19 Jan 06	Action & Update	Light beam diaphragms for diagnostic x-ray equipment: Light beam diaphragms(LBDs), also known as collimators, have become detached from x-ray tubes during routine clinical use, occasionally leading to patient injury (PDF 136 KB)
MDEA(NI)2006 02	13 Jan 06	Immediate Action	Fisher and Paykel healthcare adult breathing circuits - dual heated: Model Numbers RT100, RT104, RT200, RT204, RT026 AND 900MR914. BATCH NUMBERS 041101 TO 050331: Risk of fire and burns with specific batches of breathing circuits (PDF 139 KB)
MDEA(NI)2006/01	03 Jan 06	Action & Update	Reporting Adverse Incidents and Disseminating Medical Device/Equipment Alerts (PDF 81 KB)

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