BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 21097530 · Received January 7, 2025

    Report

    Report Number
    1220648-2025-25395
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, AN INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: SECTION: CLEANING. ¿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 OF PURGE LEAK ¿ PUMP HAS BEEN COMPLETED. THE PRODUCT WAS NOT RETURNED. DUE TO LIMITED CLINICAL DETAILS AND NO PRODUCT RETURNED, THE ROOT CAUSE OF THE PURGE LEAK - PUMP CANNOT BE DETERMINED. THE FOLLOWING HAVE BEEN REPORTED INCORRECTLY OR MISSING FROM MANUFACTURER DEVICE REPORT 1220648-2025-25395.

    Description of Event or Problem · 0

    US COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA 5.5 SUPPORT WHILE ON SUPPORT, THE NURSE CALLED IN STATING THE PURGE FLUID IS LEAKING OUT OF THE FILTER/PURGE RESERVOIR AREA. ADDITIONALLY, A HEMATOMA WAS NOTED AT THE AXILLARY ACCESS SITE. NO INTERVENTION WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012429 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025572823 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female