Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2017 – 31.08.2017

Опубліковано 01.11.2017 о 00:00


 

 

Великобританія

https://www.gov.uk/drugdevicealerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

 

·                     Replacement bileaflet mechanical heart valves – risk of inverted implantation

Specific manufacturers – measures to prevent inverted valve implantation resulting from incorrect mounting of the valve on its valve holder.

Alert type: Medical device alert Medical specialism: Cardiology and 1 others Issued: 31 August 2017

·                     Replacement bileaflet mechanical heart valves – risk of inverted implantation

Specific manufacturers – measures to prevent inverted valve implantation resulting from incorrect mounting of the valve on its valve holder.

Alert type: Medical device alert Medical specialism: Cardiology and 1 others Issued: 31 August 2017

·                     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)

Alert type: Medical device alert Medical specialism: Anaesthetics and 3 others Issued: 24 August 2017

·                     Overhead hoist: Freeway Easy Fit system with a swivelling 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.

Alert type: Medical device alert Medical specialism: Care home staff and 1 others Issued: 24 August 2017

·                     Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection

Manufactured by Zimmer Biomet – Recall due to risk of infection if the wire breaks through the packaging (MDA/2017/025)

Alert type: Medical device alert  Medical specialism: Care home staff and 4 others Issued: 24 August 2017

·                     Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection

Manufactured by Zimmer Biomet – Recall due to risk of infection if the wire breaks through the packaging (MDA/2017/025)

Alert type: Medical device alert Medical specialism: Care home staff and 4 others Issued: 24 August 2017

·                     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)

Alert type: Medical device alert Medical specialism:  Care home staff and 3 others Issued:24 August 2017

·                     Shoulder system: Comprehensive Nano Humeral Components – increased risk of revision when used in reverse configuration

Manufactured by Zimmer Biomet – do not use this device in the reverse configuration. (MDA/2017/023)

Alert type: Medical device alert Medical specialism: Orthopaedics  Issued: 18 August 2017

·                     Shoulder system: Comprehensive Nano Humeral Components – increased risk of revision when used in reverse configuration

Manufactured by Zimmer Biomet – do not use this device in the reverse configuration. (MDA/2017/023) Alert type: Medical device alert Medical specialism: Orthopaedics Issued:

18 August 2017

·                     DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade: risk of infection

Manufactured by Synthes GmbH – Recall due to risk of infection from cracked weld of the handle.

Alert type: Medical device alert Medical specialism: Anaesthetics and 21 others  Issued: 17 August 2017

·                     DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade: risk of infection

Manufactured by Synthes GmbH – Recall due to risk of infection from cracked weld of the handle.

Alert type: Medical device alert Medical specialism: Anaesthetics and 21 others Issued: 17 August 2017

·                     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 type: Medical device alert Medical specialism: Anaesthetics and 21 others Issued: 14 August 2017

·                     Haemofiltration machine: all Prismaflex systems installed with software version 6.10 – risk of under-infusion of anticoagulant

Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.

Alert type: Medical device alert Medical specialism: Anaesthetics and 21 others Issued: 11 July 2017

·                     Haemofiltration machine: all Prismaflex systems installed with software version 6.10 – risk of under-infusion of anticoagulant

Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.

Alert type: Medical device alert Medical specialism: Anaesthetics and 21 others Issued: 11 July 2017

·                     Unomedical high concentration oxygen masks (specific lots) – risk of hypoxia as the tubing can disconnect from the oxygen mask

Manufactured by ConvaTec – due to a manufacturing fault, the tubing may disconnect from the oxygen mask, prior to use or during use, causing a disruption in the supply of oxygen to patients (MDA/2017/019)

Alert type: Medical device alert Medical specialism: Anaesthetics and 21 others Issued: 10 July 2017

 

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