Medical Device Alerts issued in November 2018
Alerts were issued about ConvaTec Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags, CME T34 ambulatory syringe pumps, and HeartStart MRx monitor/defibrillators.
In this monthly update, we highlight selected Medical Device Alerts that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.
The following alerts were recently issued:
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Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags – potential breach in sterile barrier packaging (MDA/2018/034). Issued 14 November 2018. Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients getting infections.
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All T34 ambulatory syringe pumps – update concerning battery information (MDA/2018/035). Issued 14 November 2018. Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump
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Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power. Issued 29 November 2018. Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.
Article citation: Drug Safety Update volume 12, issue 5: December 2018: 7.