Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.11.2017 – 31.12.2017

Великобританія

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

·         AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery – unexpected surge to maximum speed and failure of the emergency stop

Risk of injury to the patient if the treadmill suddenly goes to top speed.

Alert type: Medical device alert Medical specialism: Cardiology and 3 others Issued:

21 December 2017

·         Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion

BD Alaris/Asena syringe pumps (specific product codes) – internal malfunction may cause PL3 alarm to sound and the infusion to stop (MDA/2017/036).

Alert type: Medical device alert Medical specialism: Anaesthetics and 11 others Issued:

20 December 2017

·         Nasogastric (NG) feeding tubes – recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap

Manufactured by Maxter Catheters – patients could accidentally pull off the connector cap and choke on it. (MDA/2017/035)

Alert type: Medical device alert Medical specialism: Paediatrics Issued:19 December 2017

·         ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc – potential for false resistance results if stored at the wrong temperature

Manufactured by Oxoid Ltd (ThermoFisher Scientific) – antibiotic (ceftazidime) concentration may decrease over time if test disc is stored between 2°C and 8°C: only specific lots are affected (MDA/2017/034)

Alert type: Medical device alert Medical specialism: Infection prevention and 1 others Issued:

23 November 2017