Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2017 – 30.06.2017

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

 

 

·         All metal-on-metal (MoM) hip replacements: updated advice for follow-up of patients

MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018)

Alert type:

Medical device alert

Medical specialism:

General practice and 3 others

Issued:

29 June 2017

·         BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment

Manufactured by Intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 5 others

Issued:

21 June 2017

·         DePuy Synthes Radial Head elbow prosthesis system: risk of post-operative loosening of the radial stem

Manufactured by Synthes GmbH – Recall of Radial Head Prosthesis System.

Alert type:

Medical device alert

Medical specialism:

Orthopaedics

Issued:

12 June 2017

·         Solus Flexible Wire Reinforced Laryngeal Mask Airway – risk of hypoxia due to partial or total occlusion of the airway tube after inflating the cuff

Manufactured by Intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 6 others

Issued:

9 June 2017

·         All HeartStart MRx defibrillators – possible failure to deliver a shock, cardioversion, pacing or monitoring

Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 18 others

Issued:

24 May 2017

·         All LIFEPAK 1000 automatic external defibrillators (AEDs) – risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy

Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 21 others

Issued:

18 May 2017

·         V60 ventilator – potential for unexpected shutdown

Manufactured by Philips Respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 3 others

Issued:

17 May 2017

·         Biological replacement pericardial aortic heart valve: Mitroflow LX (sizes 19mm and 21mm) – risk of early structural valve deterioration

Manufactured by LivaNova – increased risk of earlier than anticipated structural valve deterioration (SVD) particularly with the smaller sizes.

Alert type:

Medical device alert

Medical specialism:

Cardiology

Issued:

3 May 2017

·         All Accu-Chek® Insight insulin pumps – updated information for battery management

Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.

Alert type:

Medical device alert

Medical specialism:

Care home staff and 3 others

Issued:

2 May 2017

·         BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy

Manufactured by Becton Dickinson (BD) – product recall due to leak around the stopper which can result in under-dose or exposure of clinicians or patients to cytotoxic drugs.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 7 others

Issued:

24 April 2017

·         LMA mucosal atomization devices – topical anaesthesia may not be delivered in a fully atomised spray

Manufactured by Teleflex – Poor atomisation of the spray could result in inadequate topical anaesthesia delivery, which may lead to discomfort or difficulties delivering anaesthesia

Alert type:

Medical device alert

Issued:

24 April 2017

·         LMA® MAD Nasal™ intranasal mucosal atomization device – might not deliver a fully atomised plume of medication

Manufactured by Teleflex – failure of the device to deliver an atomised plume may impair the effectiveness of the medication, potentially resulting in serious injury or a life-threatening situation

Alert type:

Medical device alert

Issued:

21 April 2017

·         All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine

Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 4 others

Issued:

12 April 2017

·         Comprehensive Reverse Titanium Shoulder Tray (specific lots) – risk of device fracture

Manufactured by Zimmer Biomet – recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.

Alert type:

Medical device alert

Medical specialism:

General practice and 2 others

Issued:

4 April 2017