NIAIC Whats New
- 15 May 2013
MDA-2013-034 (PDF67 KB)
RÜSCH Macintosh laryngoscopes. Disposable laryngoscope metal kit, disposable laryngoscope battery handles and reusable laryngoscope handles. Manufactured by M.A. Arain & Brother (PVT) Ltd. Distributed in the UK by Teleflex (RÜSCH). Specific lot numbers are affected. There is potential for the light to flicker or fail during intubation due to a loose connection between the battery and the battery cap.
- 10 May 2013
MDA/2013/033 (PDF 39 KB)
Diacap® Ultra dialysis fluid filter. Manufactured by B. Braun Avitum AG. Product code: 7107366. All devices that are more than 10 months from the date of manufacture are affected. Risk of a gradual increased fluid removal, which may cause symptoms of hypotension during dialysis treatment. Ultrafiltration deviations may not be immediately detected by the machine. This is due to a decrease in the residual moisture of the filter membrane, which can cause a higher fluid removal from the patient than initially selected.
- 10 May 2013
MDA/2013/032 (PDF 36 KB)
Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules. All manufacturers and all models. Risk of inadequate external pacing, leading to potential periods of asystole, syncope and possible death. Factory default start-up pacing current and rate settings on transcutaneous pacemaker modules vary and may be too low to ensure pacing capture. Users should be aware of this and ensure settings are configured to meet their local protocols. Transcutaneous pacing modules have factory defaults that initiate pacing with a low current and rate. The MHRA has received a report that highlights the importance of raising awareness that the factory defaults can be configured to user presets. Further guidance on trancutaneous pacing is being considered by Heart Rhythm UK (HRUK).
- 10 May 2013
MDA/2013/031 (PDF 32 KB)
Hospital beds: Dynamis and Gerialit with Dewert electrical controlsystems. Manufactured by Hill-Rom. Specific models numbers manufactured from October 1995 to June 2001 inclusive. Risk of serious injury to patients, staff and visitors. Unintentional movement, including sudden collapse to its lowest position, can occur when the bed is connected to the mains supply. A Field Safety Notice (FSN) was published on 01 March 2012. However, the manufacturer has since advised that these beds should be fixed to their lowest position and the control system deactivated to remove the risk of injury.
- 09 May 2013
MDA/2013/030 (PDF 37 KB)
Single-use syringes: 50 ml Luer lock. Manufactured by Terumo Europe.
Product code BS-50LG (NHS Supply Chain code FWC245).
Lot numbers 1208001, 1208002 and 1208003.
Risk of delay or interruption to treatment when affected syringes are used in syringe pumps. Some syringes in the affected batches require a greater force than usual to push the plunger. This can lead to false occlusion alarms being triggered when they are used in syringe pumps. Terumo issued a Field Safety Notice (FSN) in February 2013 recalling the three batches affected by this manufacturing problem.
- 08 May 2013
MDA/2013/029 (PDF 40 KB)
Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet. Manufactured by Unomedical (a ConvaTec company). Available under three brand names:
• Unomedical UnoFlexTM
• EuromedicalTM TrachealFlexTM
Specific sizes and lots are affected.Potential for inadequate patient ventilation. The affected tubes may delaminate, which can lead to constriction of the lumen, resulting in a reduction of airflow to the patient. The manufacturer issued a Field Safety Notice, dated 13 March 2013, to withdraw the affected devices buthas not had confirmation from a significant number of users that they have received and acted upon this information. This alert has been issued in support of the manufacturer’s actions.