Medical device alerts archived in October 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
| Reference | Title |
| Solus Flexible Wire Reinforced Laryngeal Mask Airway 鈥� risk of hypoxia due to partial or total occlusion of the airway tube after inflating the cuff. Manufactured by Intersurgical | |
| BVM (Bag-Valve-Mask) manual resuscitation systems 鈥� risk of delay to emergency treatment. Manufactured by Intersurgical | |
| Unomedical high concentration oxygen masks (specific lots) - risk of hypoxia as the tubing can disconnect from the oxygen mask. Manufactured by ConvaTec | |
| VITEK庐2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards 鈥� 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 BioM茅rieux | |
| Insulin pens: NovoPen Echo and NovoPen 5 (certain batches) 鈥� risk of hyperglycaemia due to cartridge holder weakening when exposed to certain household chemicals | |
| Nail intramedullary fixation system: Trauma guide wires 70cm 鈥� risk of infection | |
| Overhead hoist: Freeway Easy Fit system with a swivelling trolley 鈥� risk of fixing pin moving or splaying | |
| Intra-aortic balloon pump (IABP): CS100, CS100i and CS300 鈥� risk of haemodynamic instability to patients with critical conditions due to a delay in or sudden interruption of therapy | |
| Lung ventilators: Astral 100, 100SC and 150 鈥� potential power loss due to faulty battery | |
| All Accu-Chek庐 Insight insulin pumps 鈥� risk of alarm failure | |
| IntelliVue patient monitors used with 12-lead ECG 鈥� risk of ECG trace distortion Specific models and software versions affected. Manufactured by Philips Healthcare | |
| Intra-aortic balloon pump (IABP): Maquet/Datascope CS100, CS100i and CS300 鈥� potential for interruption or delay to therapy of critically ill patients | |
| Professional use HIV test: Alere HIV Combo 鈥� risk of false positive results | |
| ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc | |
| Nasogastric (NG) feeding tubes 鈥� recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap. Manufactured by Maxter Catheters | |
| Syringe pumps 鈥� required user actions in the event of PL3 alarm to prevent risk of interrupted infusion. Manufactured by BD Alaris/Asena | |
| AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery 鈥� unexpected surge to maximum speed and failure of the emergency stop | |
| In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products 鈥� precautionary measure | |
| Recall of specific lots of RUSCH sensor (series 400) silicone and non-sterile rectal/ pharyngeal temperature sensors | |
| Roche Tissue Diagnostics (Ventana Medical Systems) 鈥� OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II 鈥� Dispenser failure of Hematoxylin II and Horseradish Peroxidase reagents. | |
| Zimmer Biomet, specific hip and trauma instruments: risk of infection | |
| Bag valve mask (BVM) manual resuscitation system 鈥� risk of damage to lungs by delivery of excessive pressure. | |
| All T34 ambulatory syringe pumps 鈥� risk of unintended pump shutdown and delay to treatment | |
| Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision 鈥� Risk of revision | |
| Device: BD Vacutainer庐 EDTA & BD Vacutainer庐 Lithium Heparin Tubes 鈥� risk of incorrect results for lead testing or other assays using ASV methodology | |
| cobas b 221 instruments with AutoQC module 鈥� software limitation affecting automatic QC measurements | |
| Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 鈥� risk that alarms are not activated | |
| Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips 鈥� risk of strip error messages and false high and low blood glucose results. | |
| Cook Vacuum Pump for IVF 鈥� risk of electric shock or burn to operator | |
| Various Arrow Critical Care devices 鈥� recall due to incomplete packaging seals | |
| JM103 and JM105 Jaundice Meters 鈥� risk of misinterpretation of measurement in hyperbilirubinemia cases | |
| Smiths Medical CADD庐 Non Flow-Stop Medication Cassette Reservoirs 鈥� recall of specific lots due to risk of under delivery of medication | |
| Alaris Smartsite Add-On Bag Access device 鈥� removal and destruction of specific batches due to risk of disconnection or leakage | |
| SAM XT Extremity Tourniquet - Recall due to the risk of tourniquet failing in use | |
| Combur10 Test UX and Chemstrip 10 A test strips 鈥� risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser | |
| All Alaris鈩� and Asena鈩� GS, GH, CC, TIVA, PK, enteral syringe pumps-risk of uncontrolled bolus of medicine. |
Updates to this page
Published 7 October 2021