BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 17595933 · Received August 22, 2023

    Report

    Report Number
    1220648-2023-02784
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 24, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE PURGE SIDEARM LEAK HAS BEEN COMPLETED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE PURGE LEAK WAS UNABLE TO BE DETERMINED BECAUSE THE PRODUCT WAS NOT RETURNED AND LIMITED CLINICAL DETAILS WERE 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.¿ ¿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 67-YEAR-OLD MALE WAS IMPLANTED WITH AN IMPELLA 5.5 AS A BRIDGE TO TRANSPLANT. DURING SUPPORT, A FLUID LEAK WAS IDENTIFIED FROM THE PURGE SIDE ARM DURING IMPELLA SUPPORT. DESPITE THE NOTED LEAK, THE PURGE FLOW AND PURGE PRESSURE WERE BOTH STILL WITHIN NORMAL LIMITS. AS A RESULT OF THE LEAK, THE SITE WAS ADVISED TO REPLACE THE IMPLANTED PUMP. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52572 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2024329673 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male