BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18920452 · Received March 18, 2024

    Report

    Report Number
    1220648-2024-08132
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    March 8, 2024
    Report Date
    June 5, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED CONSOLE (AIC) CONTROLLER FAILURE ALARM HAS BEEN COMPLETED. THE AIC WAS RETURNED FOR EVALUATION. THE CONSOLE WAS VISUALLY INSPECTED AND FOUND TO HAVE NO OBSERVABLE DEFECT. THE POWER SUPPLY FROM PBM TO THE PUD WAS FOUND TO BE NOMINAL AT ABOUT 5V. THE FAILURE WAS REPRODUCED ON BOOT UP OF THE CONSOLE IN THE LAB. IT WAS FOUND THAT THE ALARM HAD NO OBSERVABLE EFFECT ON THE PERFORMANCE OF THE PURGE SYSTEM WHEN A KNOWN GOOD PUMP AND PURGE LINE WERE PLUGGED INTO THE CONSOLE. THE PUD FIRMWARE WAS EXTRACTED AND COMPARED WITH PRODUCTION CODE. IT WAS FOUND TO BE CORRUPTED. DATA LOGS WERE REVIEWED WHICH CONFIRM THAT THE CONTROLLER FAILURE (PUD SW CORRUPTION) ALARM WAS ISSUED ON DATE OF OCCURRENCE THE ROOT CAUSE FOR THE CONTROLLER FAILURE WAS A PURGE UNIT DRIVER WITH CORRUPTED FIRMWARE. IN ACCORDANCE WITH UPDATED PROCEDURES, SECTION D2 HAS BEEN REVISED FROM THE INITIAL SUBMISSION.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CONTROLLER FAILURE ALARM OCCURRED. THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS EXCHANGED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018887 AUTOMATED IMPELLA CONTROLLER CONTROL,, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1725570 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown