Warning over trio of medical devices

Published: 28-Aug-2013

Syringes, IV extension set and heart defibrillator subject of alerts by regulator

Single-use syringes, an IV extension set, and a heart defibrillator are all the subject of fresh warnings by the Medicines and Healthcare products Regulatory Agency (MHRA).

The regulator has issued a trio of Medical Device Alerts amid concerns over the efficacy of the equipment.

The first concerns Plastipak 50ml Luer Lok syringes manufactured by BD Medical. Specific lot numbers are affected amid fears of an under delivery of medication to patients. Syringes from the affected batches may have a den or indentation on the syringe barrel which may cause leakage inside the syringe, between the plunger and the barrel. Hospitals are being warned to identify those products affected and quarantine them.

Secondly, the MHRA is highlighting problems with the Vygon Protect-A-Line IV extension set. The alert only affects batch numbers ending in BA which could pose a risk of air embolus because affected devices have been supplied with vented caps on the female port instead of non-vented caps.

The third concerns the HeartStart XL defibrillator/monitor with M3516A batteries from Philips. It only affects lots with an LK prefix, where defibrillator battery life has been reduced from 1.5 years to one year and the capacity test interval has been reduced from six months to three months. Batteries with lot code prefixes ‘P’, ‘R’, and ‘PCS’ are not affected by the change.

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