BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE, STERILE, NON-QSK

    MDR report key: 23954312 · Received January 4, 2026

    Report

    Report Number
    1220648-2026-00042
    Event Type
    Malfunction
    Date Received
    January 4, 2026
    Date of Event
    December 24, 2025
    Report Date
    January 4, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 REVISED DATE OF EVENT AS IT WAS ENTERED INCORRECTLY ON THE INITIAL REPORT THAT WAS SUBMITTED. D9 DEVICE WAS RECEIVED AND DATE RECEIVED WAS ADDED. H6 UPDATED CODES TO REFLECT THE DEVICE WAS RETURNED. H11 UPDATED ADDITIONAL MANUFACTURER NARRATIVE AS THE DEVICE WAS RECEIVED. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT BEFORE IMPLANTATION, THE CASSETTE'S LUER LOCK WAS LEAKING, SO IT WAS CHANGED TO ANOTHER CASSETTE AND THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15206 PURGE CASSETTE, STERILE, NON-QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PURGE CASSETTE, STERILE, NON-QSK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male