Health Canada — Medical Devices · Canada · 2022-04-11 · Type I
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Reported risk: Smiths Medical became aware of eight (8) issues-(identified below) that can potentially occur that may impact therapy delivery in specific Medfusion 3500 and 4000 syringe infusion pumps. 1. Primary Audible Alarm (PAA) 2. Unanticipated depleted battery alarms 3. Time Base Alarm 4. Intermittent Volume Over Time (IVOT) - Infusion continues after system fault 5. Clearing of Program Volume Delivered (PVD) 6. False Alarm for Rate below recommended minimum for syringe size 7. Incorrect bolus or loading dose time display 8. Domain Name Server (DNS) port 1001 and when some of these issues happen, It may lead to delay in therapy or interruption of therapy, which may result serious injuries to patients. Recall start date: Mar 28, 2022
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