Impella

Description of Event or Problem

The complainant reported that during Impella RP support, a yellow ¿Placement Signal Not Reliable ¿ Monitor Patient's Hemodynamic Parameters¿ alarm was observed on the Automated Impella Controller (AIC). Following the alarm, placement signal parameters, waveforms, and pump flow information were no longer displayed on the console. Motor current remained visible.Troubleshooting was performed, including re-zeroing the placement signal; however, the condition persisted. 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 patient was reported to be clinically stable, and the device continued to provide support despite the loss of displayed placement signal parameters and waveforms.At the time of this report, the patient remains on Impella RP support. No signs or symptoms of patient injury or patient harm were reported in association with this event.

Additional Manufacturer Narrative

A. PATIENT INFORMATION is unknown.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.