Arrow International LLC , EIF-000522, Arrow AutoCAT Intra-Aortic Balloon Pump

Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a voluntary Field Safety Corrective Action (FSCA) for the product codes referenced above due to a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. These IABP devices can be powered either by connecting to an AC power source or with battery power for mobile use. When operating the IABP device using battery power, the expected duration of pumping, after a full charge, is 90 minutes. However, Teleflex has received complaints reporting that some users of the affected IABP devices have experienced short battery run-times, including loss of power during use. The IABP is designed with alarms to indicate that there are 20, 10, and 5 minutes of battery life remaining. In the past two years, Teleflex has received one complaint reporting that the unit shut offm Page 2 of 5 without the time remaining alarms and thirteen complaints reporting missing alarms, where the time remaining was reported to be inaccurate based on how quickly the battery was depleting. The immediate health consequences of battery failure are the cessation of intra-aortic balloon counter-pulsation with a potentially life-threatening reduction in cardiac output, which if left untreated, could result in death. As of October 11, 2022, no patient injuries or deaths have been reported.

Fabrikant: Arrow International LLC 
Product: Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series; AC3™ Series IABP System
Datum FSN: (documentdatum) 16-11-2022

Waarschuwing van de fabrikant

Dit bericht is een waarschuwing van de fabrikant. Na het op de markt brengen van een medisch hulpmiddel is de fabrikant verplicht het hulpmiddel te volgen en waar nodig te verbeteren. Wanneer sprake is van een risico voor de gebruiker moet de fabrikant actie ondernemen. De fabrikant informeert gebruikers en de inspectie over deze actie met een waarschuwing (Field Safety Notice). Zie ook waarschuwingen medische hulpmiddelen. Dit hoort bij het toezicht op medische technologie.