BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20637841 · Received November 8, 2024

    Report

    Report Number
    1220648-2024-22512
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    May 2, 2022
    Report Date
    November 7, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE AIC -PURGE DISC/ FLAG ISSUE HAS BEEN COMPLETED. THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS RETURNED FOR INVESTIGATION. CONSOLE LOGS ON THE COMPLAINT DATE WERE RETRIEVED. IMC LOGS FROM THE COMPLAINT DATE WERE CONSISTENT WITH THE CI. AFTER FEW DAYS OF SUPPORT, PURGE CASSETTE WAS ABOUT TO BE CHANGED VIA PURGE CASSETTE CHANGE WIZARD. HOWEVER, CONSOLE REPORTED FOR FLUSH FLUID NOT DETECTED DESPITE OF ATTEMPTS OF DE-AIRING. STAFF ALSO ATTEMPTED TO TROUBLESHOOT BY REMOVING AND RE-INSERTING THE SAME PC, YET THE ISSUE PERSISTED. THEREFORE, THE PROCEDURE COULD NOT BE COMPLETED. VISUAL INSPECTION OF THE PURGE ASSEMBLY AREA CONFIRMED A BROKEN BLUE RETAINER AT THE SCREW POST. THE FAILURE MODE WAS DUE TO BROKEN/ MISSING PURGE RETAINER. SEE ATTACHED IMAGE. BEFORE RETURNING THIS CONSOLE BACK TO THE CUSTOMER, FIELD SERVICE WAS INSTRUCTED TO REPLACE THE PURGE FLAG AND RETAINER, CLEAN THE PURGE ASSEMBLY, AND PERFORM PREVENTIVE MAINTENANCE SECTION 10-12 (0042-7309) AND FUNCTIONAL CHECK ON CONSOLE AND OPTICAL SYSTEM. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK ON AN AUTOMATED IMPELLA CONTROLLER (AIC) FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED AN AUTOMATED IMPELLA CONSOLE (AIC) FAILING TO RECOGNIZE A NEW CASSETTE, UPON ROUTINE CHANGE. A NEW CONSOLE WAS USED WITHOUT ANY INJURY/HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877048 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 2023175083

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male