BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21587688 · Received March 12, 2025

    Report

    Report Number
    1220648-2025-26675
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 31, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010985
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONSOLE (AIC) CONTROLLER FAILURE-RED ALARM HAS BEEN COMPLETED. DATA LOGS WERE REVIEWED FINDING THE PURGE COMMUNICATION FAILS AND NEVER RECOVERS. THIS TRIGGERS A PUD COMMUNICATION LOSS CONTROLLER FAILURE AS NOTICED IN THE COMPLAINT AND THE PUD IS POWER CYCLED MULTIPLE TIMES. DURING FUTURE BOOT UPS, THE CONSOLE IS NOT ABLE TO COMPLETE BOOT UP DUE TO THE LACK OF PURGE COMMUNICATION AND CONTINUOUSLY TRIGGERS THE SW WATCHDOG. THE AIC WAS RETURNED FOR EVALUATION. THIS FAILURE WAS REPRODUCED REPEATEDLY DURING TESTING. REPLACING THE PUD PCB, THE FAILURE MODE RESOLVED. THE ORIGINAL PCB WAS EXAMINED CLOSER OUTSIDE OF THE CONSOLE AND CAPACITOR C9.1 WAS FOUND TO BE BROKEN AND A FLUID FROM AN UNKNOWN SOURCE HAD LEAKED EXTENSIVELY OVER THE BOARD INCLUDING THE COMMUNICATION TRACE WHICH IS WHAT CAUSED THE LOSS OF COMMUNICATION. THE CONTROLLER FAILURE WAS TRIGGERED BY A LOSS OF COMMUNICATION TO THE PUD WHICH WAS CAUSED BY CAPACITOR C9.1 BREAKING AND AN UNKNOWN CAPACITIVE LIQUID LEAKING ONTO AND CORRODING THE PCB. CORRECTIONS TO THE INITIAL MFR REPORT: D2 COMMON DEVICE NAME UPDATED H5 SHOULD HAVE BEEN NO.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING DAY 2 OF SUPPORT, THE AUTOMATED IMPELLA CONTROLLER PRESENTED A CONTROLLER FAILURE ALARM. THE CONTROLLER WAS SWAPPED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548368 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1432077 00813502010985

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female