BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 18307897 · Received December 11, 2023

    Report

    Report Number
    1220648-2023-05339
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 16, 2023
    Report Date
    April 9, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE HIGH PURGE PRESSURE ISSUE HAS BEEN COMPLETED SINCE THE INITIAL REPORT WAS SUBMITTED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. AS PER CLINICAL DETAILS, THE DOCTOR REPORTED A HIGH PURGE PRESSURE ALARM WITH NO VISIBLE KINK. THE CAUSE OF THE HIGH PURGE PRESSURE ISSUE WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED AND LIMITED CLINICAL INFORMATION WAS PROVIDED.

    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. 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.¿

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 45-YEAR-OLD MALE NOTED AS HIGH RISK PERCUTANEOUS CARDIAC INSERTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED THE IMPELLA HAD HIGH PURGE PRESSURE/SYSTEM BLOCKED ALARMS. THERE WAS NO KINKS THAT WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777761 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2024397191 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male