Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2020 – 29.02.2020

Опубліковано 02.03.2020 о 13:29

Великобританія

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


  1. Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models

Manufactured by Cardinal Health – calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 14 others

 Issued: 27 February 2020

  1. Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users (MDA/2020/008)

Manufactured by Olympus Medical Systems Corp – instructions for use now say to inspect for frayed elevator wires before and after use to improve the detection of damage.

  • Alert type: Medical device alert

 Medical specialism: General surgery and 2 others

 Issued: 27 February 2020

  1. All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm (MDA/2020/007)

Manufactured by CME (a BD company) – updated advice to address ‘wear and tear’ of the syringe pump motor block which may lead to under-infusion.

  • Alert type: Medical device alert

 Medical specialism: Care home staff and 1 others

 Issued: 25 February 2020

  1. Self-expanding stents (S.M.A.R.T. and PRECISE) under MRI – various risks if MRI is operated outside the required conditions for these stents (MDA/2020/006)

Manufactured by Cordis – instructions for use contain incorrect MRI compatibility information.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 6 others

  • Issued: 13 February 2020
  1. t:slim X2 insulin pump – discard or destroy defective mains (A/C) power adapters (MDA/2020/005)

Manufactured by Tandem Diabetes Care – an exposed component may cause an electrical shock to the user or patient

  • Alert type: Medical device alert

 Medical specialism: Care home staff and 2 others

 Issued: 5 February 2020

  1. Skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection (MDA/2020/004)

Manufactured by Mavidon – products may be contaminated with the microorganism Burkholderia cepacia leading to an infection risk to patients.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 17 others

 Issued: 5 February 2020

  1. Professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) – risk of failure to deliver therapy (MDA/2020/003)

Manufactured by Philips – due to hardware or software issues (described in two separate FSNs) the device may fail to start, unexpectedly restart or deliver defibrillation therapy at the wrong energy level.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 17 others

 Issued: 28 January 2020

  1. Convex two-piece skin barriers (Natura /Surfit/Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier (MDA/2020/002)

Manufactured by ConvaTec – specific batches of convex two-piece skin barriers have been incorrectly manufactured with off-centre starter/stoma hole.

  • Alert type: Medical device alert

 Issued: 16 January 2020

  1. NIPPY ventilator range (all models) – update to instructions for use (MDA/2020/001

Manufactured by Breas Medical Limited – maintenance schedule now includes changing the internal memory/alarm battery every 3 years.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 2 others

 Issued: 15 January 2020

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