Medical device alerts archived in October 2021

Source:  MHRA 7/10/21

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

MDA/2017/015 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
MDA/2017/017 BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment. Manufactured by Intersurgical
MDA/2017/019 Unomedical high concentration oxygen masks (specific lots) – risk of hypoxia as the tubing can disconnect from the oxygen mask. Manufactured by ConvaTec
MDA/2017/021 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
MDA/2017/024 Insulin pens: NovoPen Echo and NovoPen 5 (certain batches) – risk of hyperglycaemia due to cartridge holder weakening when exposed to certain household chemicals
MDA/2017/025 Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection
MDA/2017/026 Overhead hoist: Freeway Easy Fit system with a swivelling trolley – risk of fixing pin moving or splaying
MDA/2017/027 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
MDA/2017/029 Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery
MDA/2017/030 All Accu-Chek® Insight insulin pumps – risk of alarm failure
MDA/2017/031 IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion Specific models and software versions affected. Manufactured by Philips Healthcare
MDA/2017/032 Intra-aortic balloon pump (IABP): Maquet/Datascope CS100, CS100i and CS300 – potential for interruption or delay to therapy of critically ill patients
MDA/2017/033 Professional use HIV test: Alere HIV Combo – risk of false positive results
MDA/2017/034 ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc
MDA/2017/035 Nasogastric (NG) feeding tubes – recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap. Manufactured by Maxter Catheters
MDA/2017/036 Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion. Manufactured by BD Alaris/Asena
MDA/2017/037 AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery – unexpected surge to maximum speed and failure of the emergency stop
MDA/2018/003 In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products – precautionary measure
MDA/2018/004 Recall of specific lots of RUSCH sensor (series 400) silicone and non-sterile rectal/ pharyngeal temperature sensors
MDA/2018/005 Roche Tissue Diagnostics (Ventana Medical Systems) – OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II – Dispenser failure of Hematoxylin II and Horseradish Peroxidase reagents.
MDA/2018/007 Zimmer Biomet, specific hip and trauma instruments: risk of infection
MDA/2018/009 Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure.
MDA/2018/010 All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment
MDA/2018/011 Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision
MDA/2018/012 Device: BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology
MDA/2018/013 cobas b 221 instruments with AutoQC module – software limitation affecting automatic QC measurements
MDA/2018/014 Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 – risk that alarms are not activated
MDA/2018/016 Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results.
MDA/2018/017 Cook Vacuum Pump for IVF – risk of electric shock or burn to operator
MDA/2018/018 Various Arrow Critical Care devices – recall due to incomplete packaging seals
MDA/2018/019 JM103 and JM105 Jaundice Meters – risk of misinterpretation of measurement in hyperbilirubinemia cases
MDA/2018/020 Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs – recall of specific lots due to risk of under delivery of medication
MDA/2018/021 Alaris Smartsite Add-On Bag Access device – removal and destruction of specific batches due to risk of disconnection or leakage
MDA/2018/022R SAM XT Extremity Tourniquet – Recall due to the risk of tourniquet failing in use
MDA/2018/023 Combur10 Test UX and Chemstrip 10 A test strips – risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser
MDA/2018/024R All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps-risk of uncontrolled bolus of medicine.

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