BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 17664483 · Received August 31, 2023

    Report

    Report Number
    1220648-2023-02937
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    November 1, 2021
    Report Date
    August 31, 2023
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502011531
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE REPORTED PURGE LEAK AND LOW PF AND PP WAS COMPLETED. THE DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED PRODUCT WAS VISUALLY INSPECTED AND A PURGE BYPASS WAS CONFIRMED. THE PUMP SIDEARM WAS NOT RETURNED FOR REVIEW. THE CAUSE OF THE PURGE LEAK WAS MOST LIKELY SIDEARM YELLOW LUER DAMAGE. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS. THE FAILURE MODES WILL BE MONITORED AND TRENDED. PER THE IFU: 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 THAT WHILE ATTEMPTING TO CHANGE THE PURGE TUBING PER HOSPITAL PROTOCOL, A LEAK WAS OBSERVED AT THE YELLOW-TO-YELLOW CONNECTION OF THE IMPELLA 5.5 PUMP. PURGE FLOW (PF) AND PURGE PRESSURE (PP) REMAINED BELOW NORMAL LIMITS. THE SURGEON PERFORMED A PURGE BYPASS TO PREVENT A POSSIBLE PUMP STOP. THE PUMP WAS SUCCESSFULLY WEANED AND REMOVED ON (B)(6) 2021. THERE WERE NO REPORTS OF HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513585 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 WITH SMARTASSIST SET, US 2022126633 813502011531

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female