BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 18778122 · Received February 26, 2024

    Report

    Report Number
    1220648-2024-07056
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 14, 2024
    Report Date
    April 4, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE DELIVERY ISSUES HAS BEEN COMPLETED SINCE THE INITIAL REPORT WAS SUBMITTED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE DELIVERY ISSUE IS DETERMINED TO BE PATIENT CONDITION BECAUSE OF THE PATIENT COMPANY.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 79-YEAR-OLD FEMALE UNDERGOING CARDIAC SURGERY WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED THAT IMPELLA CP INSERTION WAS ABORTED DUE TO THE PATIENT¿S ANATOMY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322467 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PUMP SET, PUMP 381 (US) 2024430952

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female