BEUDAMED
    FDA Adverse Event Death Summary report: N

    PURGE CASSETTE, STERILE, NON-QSK

    MDR report key: 24019460 · Received January 9, 2026

    Report

    Report Number
    1220648-2026-00433
    Event Type
    Death
    Date Received
    January 9, 2026
    Date of Event
    January 4, 2026
    Report Date
    January 21, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    B: ADDED MALFUNCTION. D6A AND D6B: UPDATED IMPLANT AND EXPLANT INFORMATION. D9: UPDATED DEVICES RETURN INFORMATION. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION/ANALYSIS IS UNDERWAY. UPON COMPLETION OF THE ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A2, A4, A5, AND A6 ARE UNKNOWN. 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 MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA PUMP EXPERIENCED A PURGE CASSETTE LEAK. THE PATIENT EXPIRED ON IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81113 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 NA Female Death