BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20594386 · Received November 2, 2024

    Report

    Report Number
    1220648-2024-21786
    Event Type
    Malfunction
    Date Received
    November 2, 2024
    Date of Event
    October 24, 2022
    Report Date
    November 2, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE CONTROLLER ERROR/KBD KNOB ISSUE HAS BEEN COMPLETED. THE IMPELLA AUTOMATED CONTROLLER WAS RETURNED FOR INVESTIGATION. THE DATA LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH THE COMPLAINT AND SHOW ALARM #24 (CONTROLLER ERROR DUE TO KBD COMM LOSS) PRECEDED BY IMC-KBD ERROR (KBD IS KEYBOARD ERROR) MESSAGES INDICATING COMMUNICATION ISSUE. SHORTLY AFTER THE ALARM, THE CONSOLE REGISTERED MULTIPLE KEYPRESSES, BUT REPORTEDLY THE SOFTWARE DID NOT RESPOND TO THE KEYPRESSES. THE PUMP WAS UNPLUGGED, AND THE CONSOLE SUCCESSFULLY SHUT DOWN (CONFIRMING THAT ROTARY PUSH-BUTTON WAS OPERATIONAL, AND SOFTWARE WAS RESPONSIVE). THE ISSUE WAS NOT REPRODUCED DURING TESTING OF THE RETURNED PRODUCT, AND THERE WAS NO DAMAGE TO ANY COMPONENTS OBSERVED DURING INSPECTION. DUE TO THE HAZARD ASSOCIATED WITH THIS MALFUNCTION PRESENTING DURING ACTIVE SUPPORT (RATHER THAN DURING AIC BOOT-UP SEQUENCE), IT IS RECOMMENDED THAT ALL COMPONENTS THAT MIGHT HAVE CONTRIBUTED TO THIS ISSUE ARE CONSIDERED SUSPECT AND ARE TO BE REPLACED. THE CAUSE OF THE ISSUE WAS NOT DETERMINED SINCE THE ISSUE COULD NOT BE REPRODUCED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) EXPERIENCED A CONTROLLER ERROR ALARM AT THE END OF THE CASE. ADDITIONALLY, IT WAS REPORTED THE SOFT KEYS FROZE, THE WHITE PLUG WAS PULLED TO SHUT THE PUMP OFF. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789144 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1136980 813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male