Impella

Description of Event or Problem

The complainant reported that during Impella RP Flex support, a ¿Placement Signal Not Reliable¿ alarm was observed on the Automated Impella Controller (AIC). The cause of the reported alarm was unknown.Troubleshooting was performed by repositioning the pump approximately 1 cm in both directions and re-zeroing the pump. Following these actions, the placement signal recovered; however, the alarm subsequently recurred. The placement signal waveform remained visible on the AIC throughout the event.Device position was assessed and confirmed to be appropriate using imaging. Neither the console nor the pump was replaced, and the device was not removed due to the reported condition. The onset of the issue did not coincide with repositioning, removal, or maintenance of a venous line.The device continued to provide support during the event. The patient was subsequently weaned from support and the device was explanted. The explant was not considered premature and was unrelated to the reported condition. The patient's outcome at the time of explant was survived.No signs or symptoms of patient injury or patient harm were reported in association with this event.

Additional Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 CFR, Part 803. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by Abiomed Inc, or its employees that the report constitutes an admission that the product, Abiomed Inc, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.