Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2018 – 28.04.2018

Опубліковано 03.05.2018 о 00:00


 

Великобританія

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

·        
BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology

Manufactured by Becton Dickinson (BD) – Due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using Anodic Stripping Voltammetry (ASV) methodology.

Medical device alert

Anaesthetics and 11 others

Issued:

26 April 2018

·         Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision

Manufactured by Biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.

Medical device alert

Orthopaedics and 1 others

Issued:

20 April 2018

·         All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment

Manufactured by Caesarea Medical Electronics (CME) Ltd – a variation in battery size can cause problems with connections in the battery housing. (MDA/2018/010)

Medical device alert

Anaesthetics and 16 others

Issued:

28 March 2018

·         Medical device alerts archived in March 2018

Following our latest review of medical device alerts, we have archived the ones listed below.

Medical device alert

Issued:

6 March 2018

·         Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure

Manufactured by Intersurgical – Valves may be incorrectly oriented, resulting in overpressure of the bag (MDA/2018/009)

Medical device alert

Anaesthetics and 13 others

Issued:

2 March 2018

 

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