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07 Sep 2017

CLH Blog - MHRA Field Safety Updates For August

CLH Blog - MHRA Field Safety Updates For August

Once again, we’ve research the many field safety alerts that have been filed over the last month and have put together a roundup of all of the most relevant MHRA updates and recalls. These focus on updates for health care products and equipment that are relevant to UK care homes and other health facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it’s important to immediately act on it.

Maquet/Datascope CS100i Intra-Aortic Balloon Pump (IABP) Maquet/Datascope CS100 Intra-Aortic Balloon Pump (IABP) Maquet/Datascope CS300 Intra-Aortic Balloon Pump (IABP)

An error that could result in an interruption and/or delay in therapy to the patient prior to and/or during use of your CS100/CS100i or CS300 IABP. This field correction also applies to any System 98 or System 98XT IABP which was converted to a CS100i or CS300 IABP.

Identification of the Issues: Maquet/Getinge has received complaints involving the CS100/CS100i and CS300 IABPs regarding the following issues: • False blood detection alarm, and • The ingress of fluids into the IABP affecting various electronic circuit boards. Either issue could potentially prevent initiation or continuation of therapy. This Field Corrective Action addresses both issues.

FSN reference: No reference.

VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards

Potential false resistance for antibiotics on the AST panel, leading to false negative ESBL test or false positive urea (URE) reaction on ID cards. Manufactured by BioMérieux – due to a manufacturing issue, some test card pouches might be damaged, resulting in antibiotic degradation.

Alert date: 14th August 2017

Novo Nordisk NovoPen Echo and NovoPen5

Insulin pens: NovoPen Echo and NovoPen 5 (certain batches) – risk of hyperglycaemia due to cartridge holder weakening when exposed to certain household chemicals. Manufactured by Novo Nordisk - recall and replacement of specific batches of cartridge holder (MDA/2017/024)

Date issued: 24th August 2017

Prism Freeway Easy Fit system with a swiveling trolley

Overhead hoist: Freeway Easy Fit system with a swiveling trolley – risk of fixing pin moving or splaying. Manufactured by Prism – splayed or misplaced pins may lead to the hoop detaching and dropping the sling.

Issue date: 24th August 2017

Datascope Corp, Intra-aortic balloon pump

Intra-aortic balloon pump (IABP): CS100, CS100i and CS300 – risk of haemodynamic instability to patients with critical conditions due to a delay in or sudden interruption of therapy. Manufactured by Datascope Corp – an electrical fault caused by a solenoid valve could mean the device fails to start or deliver therapy to patients (MDA/2017/027).

Issue date: 24th August 2017

 

Interesting reading from The Pharmaceutical Journal: MHRA publishes guide to new EU medical device laws
http://www.pharmaceutical-journal.com/news-and-analysis/news-in-brief/mhra-publishes-guide-to-new-eu-medical-device-laws/20203476.article

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