ICU Medical, Inc., MA2303-01E, Plum 360, Plum 360, Plum A+ & Plum A+3 infusion systems

ICU Medical worked with the battery supplier, CSB, to implement corrective actions in their manufacturing process for the original communicated field safety notice. Unfortunately, some batteries display behavior similar to that identified in the original notice. Therefore, ICU Medical is expanding the scope of this issue to include all batteries manufactured by CSB. ICU Medical is working with our battery supplier to resolve this issue fully. We will communicate further updates when new information becomes available. Due to a manufacturing defect from the battery supplier, Plum 360 and Plum A+ battery life may be substantially diminished. If an affected battery has diminished capacity, as defined by the triggering of the replace battery alarm, and has not been replaced, Low and Depleted Battery alarms may not trigger at the appropriate times, reducing the time the user has to plug the pump into AC power before an ongoing infusion stops and the pump shuts off.

Fabrikant: ICU Medical, Inc.
Europees vertegenwoordiger: ICU Medical BV
Product: Plum 360, Plum A+ & Plum A+3 infusion systems
Datum FSN: 27 mei 2024

Waarschuwing van 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.