Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2019 – 31.03.2019

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

 

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  Fresenius 5008 & 5008S haemodialysis machines – low risk of inadequate fluid removal during treatment (MDA/2019/018)

Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.

Alert type: Medical device alert Issued: 29 March 2019

• Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018 – risk of batteries overheating or igniting (MDA/2019/017)

Manufactured by Philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.

Alert type: Medical device alert Medical specialism:   Anaesthetics and 16 others  Issued:20 March 2019

• enFlow® IV fluid and blood warmer – risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer (MDA/2019/016)

Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.

Alert type:

 Medical device alert Medical specialism: Anaesthetics and 14 others Issued:19 March 2019

• enFlow® IV fluid and blood warmer – risk of unsafe levels of aluminium leaching from the device (MDA/2019/015)

[Archived] Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.

Alert type:

 Medical device alert Medical specialism: Anaesthetics and 14 others Issued: 19 March 2019

• All Bard urogynaecological mesh – voluntary product withdrawal, implanted devices do not need to be removed (MDA/2019/014)

Manufactured by C.R.

Alert type: Medical device alert

 Medical specialism: Obstetrics and gynaecology and 2 others

Issued:7 March 2018

• All T34 ambulatory syringe pumps – update concerning battery information (MDA/2018/035)

[Archived]Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump

Alert type: Medical device alert

 Medical specialism:  Care home staff and 3 others  Issued:14 November 2018

• All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues (MDA/2019/013)

Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – instructions provided to reduce the risk of delay to therapy and loss of infusion if the battery loses connection.

Alert type: Medical device alert

 Issued: 4 March 2019

• Potentially breached sterile packaging of: rectal tubes, Unoversal drainage systems, SimpaVac, sterile suction connecting tubes, sterile connecting pieces, suction handles/sets (FilterFlow™/Deltaflo), oxygen catheters, sterile nasal oxygen cannulas, sterile oxygen connecting tubes, and sterile forceps (MDA/2019/012)

Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients acquiring infections – extension to MDA/2018/034 as additional devices are affected

Alert type:  Medical device alert Medical specialism: Anaesthetics and 15 others

 Issued:28 February 2019

• Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B20i, B40i, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 – risk of loss of patient monitoring (MDA/2019/011)

Manufactured by GE Healthcare – If networks are incorrectly configured with multiple monitors, a prolonged bandwidth overload condition may occur and cause monitors to restart

Alert type:  Medical device alert  Medical specialism: Anaesthetics and 14 others

 Issued: 27 February 2019

• Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy

Manufactured by Stryker – potential for a lock-up condition where the device becomes non-responsive after a defibrillation shock has been delivered.

Alert type:

 Medical device alert  Medical specialism:  Anaesthetics and 18 others  Issued:20 February 2019

• Accu-Chek® Insight insulin pumps – some need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons

Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).

Alert type: Medical device alert

 Medical specialism:  Care home staff and 4 others  Issued: 19 February 2019

• Implantable cardiac pacemakers: specific brands of dual chamber pacemakers – risk of syncope due to pause in pacing therapy (MDA/2019/008)

Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (MDA/2019/008)

Alert type:

 Medical device alert  Medical specialism:  Anaesthetics and 5 others

 Issued: 13 February 2019

• Ophthalmic implant Raindrop Near Vision Inlay – risk of corneal haze (MDA/2019/007)

Manufactured by ReVision Optics, Inc – patients implanted with this device have an increased risk of corneal haze.

Alert type:  Medical device alert  Medical specialism:  General practice and 2 others

Issued: 13 February 2018

• Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening (MDA/2019/006)

Manufactured by Stryker – post-operative loosening of the implant which may require revision surgery.

Alert type:

 Medical device alert  Issued:  8 February 2019

• Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/2019/005)

Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results.

Alert type:Medical device alert 

Medical specialism:  Anaesthetics and 21 others  Issued: 30 January 2019

• Arjo Minstrel passive floor lift (portable hoist) – risk of spreader bar detachment from lifts without a scale (MDA/2019/004)

Manufactured by ArjoHuntleigh AB – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient.

Alert type:

 Medical device alert  Medical specialism:  Care home staff and 1 others  Issued: 30 January 2019

• Nellix Endovascular Aneurysm Sealing (EVAS) System – Device recall and enhanced patient surveillance (MDA/2019/002)

Endologix has stopped selling the Nellix EVAS device and is recalling unused stock.

Alert type:  Medical device alert 

Medical specialism:  Radiology and 1 others n Issued: 25 January 2019

• FreeStyle Libre flash glucose sensor – Use of barrier methods to reduce skin reactions to the sensor adhesive (MDA/2019/003)

Manufactured by Abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.

Alert type: Medical device alert 

Medical specialism: Care home staff and 3 others Issued:29 January 2019