Medical Device Alerts issued in October 2019

Alerts were issued about Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and kits, Philips Efficia professional-use defibrillators/monitors, and CME T-34 3rd edition syringe driver pumps. A notice was also issued about risk of false-low biochemistry test results in overdose of acetaminophen with use of multiple assays manufactured by Beckman Coulter.

In this monthly update, we highlight selected Medical Device Alerts and notices 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.

Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits: stop using ethyl chloride spray during the fetal blood sampling procedure with these devices (MDA/2019/035). Issued 9 October 2019. Manufactured by Rocket Medical and NuSurgix. Potential incompatibility between ethyl chloride spray and the device. Ethyl chloride spray should not be used with Rocket Medical or NuSurgix amnioscopes.

Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart (MDA/2019/039). Issued 31 October 2019. Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy. Affected devices should be identified and recommended actions carried out. Backup defibrillators should be available until the software and hardware upgrades have been undertaken.

Syringe driver pumps: T34 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released (MDA/2019/038). Issued 31 October 2019. Manufactured by CME (a BD company) – the intended operation of these pumps cannot be verified due to errors in the instructions for use (IFUs) and the incompatibility with older versions of BodyComm software (88-102). Identify patients currently receiving treatment supported by these pumps and assist them to discontinue using the device when clinically appropriate. If there is no alternative deviceaa available and it is not clinically appropriate to discontinue use, a risk assessment should be conducted and documented.

Risk of false-low biochemistry test results with multiple assays manufactured by Beckman Coulter in acetaminophen overdose

Healthcare professionals may also wish to be aware of a recent notice from Beckman Coulter to laboratories using listed assays. N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for enzymatic creatinine, triglycerides GPO blanked, uric acid, direct bilirubin, and total bilirubin testing in toxicity/overdose of acetaminophen. Acetaminophen itself is not thought to interfere with the assays.

Article citation: Drug Safety Update volume 13, issue 4: November 2019: 4.

Published 21 November 2019