BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 20015054 · Received August 21, 2024

    Report

    Report Number
    1220648-2024-15882
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    February 9, 2023
    Report Date
    August 20, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RECEIVED FROM THE CUSTOMER ON 15-FEB-2023. DATA ANALYSIS: IMC LOGS ARE REVIEWED BUT NOT RELEVANT TO THE COMPLAINT. DEVICE ANALYSIS: - CONSOLE ARRIVED IN DANVERS. - VISUAL INSPECTION OF THE PURGE ASSEMBLY AREA CONFIRMED A RIPPED BLUE RETAINER. - THE FAILURE MODE WAS DUE TO BROKEN/ MISSING PURGE RETAINER. - BEFORE RETURNING THIS CONSOLE BACK TO THE CUSTOMER, FS 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 (0042-7316).

    Description of Event or Problem · 0

    THE US COMPLAINANT HAD AN AIC (AUTOMATED IMPELLA CONTROLLER) WITH A BROKEN PURGE DISC. THERE WAS NO HARM OR INJURY NOTED AND THE IFU WAS FOLLOWED BY USE OF A BACKUP CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350443 IMPELLA CP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. IMPELLA CONTROLLER, PACKAGED, US 1283655 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown