BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP - EU

    MDR report key: 17583934 · Received August 21, 2023

    Report

    Report Number
    1220648-2023-02755
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 22, 2023
    Report Date
    October 30, 2023
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: ¿DO NOT CLEAN WITH OR EXPOSE ANY PART OF THE CLEAR SIDEARM OF THE IMPELLA CATHETER (E.G., INFUSION FILTER, PRESSURE RESERVOIR) TO ALCOHOL. ALCOHOL HAS BEEN SHOWN TO CAUSE CRACKS AND LEAKS IN THESE COMPONENTS. CAREFULLY READ LABELS ON COMMON SKIN PREPS AND LOTIONS TO AVOID USING ANY ALCOHOL-CONTAINING PRODUCTS IN THE AREA OF THE INFUSION FILTER OR PRESSURE RESERVOIR." ¿CLEAN THE CONNECTOR CABLE WITH 70% ISOPROPYL ALCOHOL.¿

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE PURGE LEAK HAS BEEN COMPLETED SINCE THE ORIGINAL REPORT WAS FILED. THE MEDICAL CENTER DID NOT RETURN THE IMPELLA DEVICE. NO BENCHTOP ANALYSIS WAS POSSIBLE; ONLY THE CLINICAL REPORT WAS EVALUATED. BASED ON THE CLINICAL INFO PROVIDED, THE ROOT CAUSE OF THE PURGE LEAK WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PURGE SYSTEM OF THE IMPELLA CP IS LEAKING DURING PATIENT'S SUPPORT. THE YELLOW LUERLOCK IS BROKEN; HOWEVER, IT IS UNCLEAR IF LEAK IS AT PURGE CASSETTE OR PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490699 IMPELLA CP - EU TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP - EU 2024342970 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Unknown