BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21423175 · Received February 20, 2025

    Report

    Report Number
    1220648-2025-26228
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 29, 2025
    Report Date
    March 20, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE AIC CONTROLLER FAILURE -RED ALARM HAS BEEN COMPLETED. DATA LOGS WERE REVIEWED AND AFTER 20 HOURS SINCE THE PUMP STARTED, THE LOG RECORDED A CONTINUOUS PUD COMMUNICATION ISSUE ERROR. DUE TO THE PERSISTENT PUD COMMUNICATION ISSUE THERE WAS PUD RESET. AFTER A COUPLE OF PUD RESETS, THE CONSOLE DISPLAYED ¿CONTROLLER FAILURE (PUD COMM LOSS) ¿ ALARM,¿ EVENT #1020. THIS CONFIRMS THE REPORTED FAILURE MODE. THIS CONSOLE WAS RETURNED FOR EVALUATION. UPON INITIAL BOOTUP, THE CONSOLE DISPLAYED A ¿SYSTEM SELF-CHECK FAILED¿ SCREEN. THE FW CHECK VIA TELNET SHOWED THAT THE PUD HARDWARE REVISION WAS N.A. IT WAS CONFIRMED THAT THE PUD FIRMWARE (FW) WAS CORRUPTED BY COMPARING IT WITH THE PRODUCTION PUD FIRMWARE. THE ROOT CAUSE OF THE CONTROLLER ERROR WAS THE CORRUPTED PUD FIRMWARE (FW). THE CAUSE OF THE CORRUPTED PUD FW WAS NOT DETERMINED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED AN AUTOMATED IMPELLA CONTROLLER (AIC) HAD A CONTROLLER FAILURE (RED ALARM) WHILE CONNECTED TO AN IMPELLA 5.5 DEVICE PROVIDING MECHANICAL CIRCULATORY SUPPORT TO A PATIENT WITH ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK. IT APPEARS THE AIC WAS NOT EXCHANGED AS THE REPORT INDICATED THE OUTCOME OF THE EVENT WAS SUCCESSFUL WITH THIS DEVICE. REPORTEDLY, THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075389 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1838437 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male