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 바카라 사이트“ 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 바카라 사이트“ 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®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards 바카라 사이트“ 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 BioMĂ©rieux | |
| Insulin pens: NovoPen Echo and NovoPen 5 (certain batches) 바카라 사이트“ risk of hyperglycaemia due to cartridge holder weakening when exposed to certain household chemicals | |
| Nail intramedullary fixation system: Trauma guide wires 70cm 바카라 사이트“ risk of infection | |
| Overhead hoist: Freeway Easy Fit system with a swivelling trolley 바카라 사이트“ risk of fixing pin moving or splaying | |
| Intra-aortic balloon pump (IABP): CS100, CS100i and CS300 바카라 사이트“ 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 바카라 사이트“ potential power loss due to faulty battery | |
| All Accu-Chek® Insight insulin pumps 바카라 사이트“ risk of alarm failure | |
| IntelliVue patient monitors used with 12-lead ECG 바카라 사이트“ 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 바카라 사이트“ potential for interruption or delay to therapy of critically ill patients | |
| Professional use HIV test: Alere HIV Combo 바카라 사이트“ risk of false positive results | |
| ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc | |
| Nasogastric (NG) feeding tubes 바카라 사이트“ recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap. Manufactured by Maxter Catheters | |
| Syringe pumps 바카라 사이트“ 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 바카라 사이트“ unexpected surge to maximum speed and failure of the emergency stop | |
| In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products 바카라 사이트“ 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) 바카라 사이트“ OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II 바카라 사이트“ 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 바카라 사이트“ risk of damage to lungs by delivery of excessive pressure. | |
| All T34 ambulatory syringe pumps 바카라 사이트“ risk of unintended pump shutdown and delay to treatment | |
| Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision 바카라 사이트“ Risk of revision | |
| Device: BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes 바카라 사이트“ risk of incorrect results for lead testing or other assays using ASV methodology | |
| cobas b 221 instruments with AutoQC module 바카라 사이트“ software limitation affecting automatic QC measurements | |
| Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 바카라 사이트“ 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 바카라 사이트“ risk of strip error messages and false high and low blood glucose results. | |
| Cook Vacuum Pump for IVF 바카라 사이트“ risk of electric shock or burn to operator | |
| Various Arrow Critical Care devices 바카라 사이트“ recall due to incomplete packaging seals | |
| JM103 and JM105 Jaundice Meters 바카라 사이트“ risk of misinterpretation of measurement in hyperbilirubinemia cases | |
| Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs 바카라 사이트“ recall of specific lots due to risk of under delivery of medication | |
| Alaris Smartsite Add-On Bag Access device 바카라 사이트“ 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 바카라 사이트“ risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser | |
| All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps-risk of uncontrolled bolus of medicine. |
Updates to this page
Published 7 October 2021