Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2020 – 30.04.2020

https://www.gov.uk/drug-device-alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

1. 
   Pilling Clear Advantage aortic punch – risk of infection due to packaging failure (MDA/2020/014)

Manufactured by Teleflex – if the packaging is not intact, the device won’t be sterile.

• Alert type: Medical device alert

 Medical specialism: Cardiology and 2 others

 Issued: 20 April 2020

2. COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013)

All manufacturers – there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death.

• Alert type: Medical device alert

 Medical specialism: Anaesthetics and 3 others

 Issued: 10 April 2020

3. Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)

All anaesthesia machines with ventilators – using the anaesthesia device in treatment of critical illness, outside its intended use is considered off-label use but may be essential due to ventilator availability.

• Alert type: Medical device alert

 Medical specialism: Anaesthetics and 2 others

 Issued: 8 April 2020

4. Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011)

Manufactured by NuVasive Specialized Orthopedics – supply of all MAGEC rods suspended to the UK market during a review by MHRA.

• Alert type: Medical device alert

 Medical specialism: Orthopaedics and 2 others

 Issued: 1 April 2020

5. Spinal implant: MAGEC System Model X rods – risk of failure in use (MDA/2020/010)

Manufactured by NuVasive Inc. – risk of end cap separation after implantation.

• Alert type: Medical device alert

 Medical specialism: Orthopaedics and 2 others

 Issued: 18 March 2020