Medical device alerts archived in October 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
| Reference | Title |
| 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. |
Published 7 October 2021