BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 17641468 · Received August 29, 2023

    Report

    Report Number
    1220648-2023-02882
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 15, 2021
    Report Date
    August 29, 2023
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011531
    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

    ONLY THE PURGE SIDEARM WAS RETURNED. A CRACK WAS OBSERVED ON THE YELLOW LUER. LEAK REPRODUCTION TESTING YIELDED LEAKING FROM ONLY THE YELLOW LUER. NO OTHER DAMAGE OR ABNORMALITIES WERE FOUND. THE CAUSE OF THE PURGE LEAK WAS SIDEARM YELLOW LUER DAMAGE DUE TO SODIUM BICARBONATE IN THE PURGE SOLUTION. THE FAILURE MODES WILL BE MONITORED AND TRENDED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 63 YEAR-OLD MALE WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THERE WAS LEAKING INSIDE THE SIDEARM RETAINER. THERE WAS NO PATIENT HARM AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082414 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2022088796 00813502011531

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male