BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    MDR report key: 23894286 · Received December 25, 2025

    Report

    Report Number
    1220648-2025-49392
    Event Type
    Malfunction
    Date Received
    December 25, 2025
    Date of Event
    September 25, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA 5.5 EXPERIENCED A PURGE SYSTEM OPEN ALARM. THE PURGE SET WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329188 PURGE CASSETTE GEN 2, STERILE, NON QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PURGE CASSETTE GEN 2, STERILE, NON QSK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male