Medical Device Alerts issued in September 2018
Alerts were recently issued by MHRA about flex connectors in Halyard closed suction kits; SureSigns VS & VM patient monitors and viewing stations; and Zimmer Biomet trauma guide wires.
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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Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation (MDA/2018/030). 19 September 2018 – Manufactured by Halyard Health. Risk of some flex connectors in closed suction kits becoming loose or disconnecting, which may interrupt patient ventilation.
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SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018: risk of batteries overheating or igniting (MDA/2018/031). 19 September 2018 – Manufactured by Philips. Lithium ion batteries which have exceeded their specified replacement interval or number of charging cycles are at risk of overheating or igniting.
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Various trauma guide wires – risk of infection due to packaging failure (MDA/2018/032). 24 September 2018 – Manufactured by Zimmer Biomet with expiry dates prior to 31 May 2028. Wire may breach packaging, compromising sterility of device.
Article citation: Drug Safety Update volume 12, issue 3: October 2018: 6.