MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; CARDIOPULMONARY BYPASS SYSTEM

Device Problems Failure to Reset (1532); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Ventricular Tachycardia (2132); Loss Of Pulse (2562)

Event Date 03/13/2017

Event Type  Death  

Event Description

A female cardiac patient was implanted with a percutaneously inserted ventricular assist device.A few days later, the lvad system console presented a "purge alarm" message instructing user to replace the purge cassette.Purge pressure at this time was within normal limits (wnl).Prior to cassette exchange patient was tilted with a pillow when console was presented a "position warning alarm" which self-resolved and displayed a "confirming this resolution" message.Staff confirmed the resolution by noting the motor waveform, purge pressure, and placement waveforms were all wnl.Shortly thereafter the console display alarmed "impella stopped" and would not respond to attempts to restart.Super-user contacted manufacturer for assistance and was advised to re-boot as last part of troubleshooting.Patient's pressure began to drop.Stat physician consult and echo request ordered.Echo imaging noted adequate impella position and physician slightly repositioned with no effects on impella performance or re-start.While scheduling stat cath lab procedure to replace impella, patient went into pulseless v-tach and expired after extensive resuscitation efforts.Impeller device released to on-site manufacturer clinical consultant and impeller controller/console sequestered for biomedical logging and evaluation.Manufacturer response for ventricular assist device, impella cp (per site reporter): manufacturer will report and disclose all findings and testing results to our facility.Manufacturer response for impella controller, impella controller (per site reporter): manufacturer in process of scheduling inspection and analysis of controller function and retrieval of logs.

• Brand Name: IMPELLA CP
• Type of Device: CARDIOPULMONARY BYPASS SYSTEM
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 6449285
• MDR Text Key: 71381577
• Report Number: 6449285
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR