Великобританія
·
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