BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    MDR report key: 23199727 · Received October 2, 2025

    Report

    Report Number
    1220648-2025-47096
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 5, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP AND THE PURGE CASSETTE WERE RETURNED FOR EVALUATION. A REVIEW OF THE DATA LOGS CONFIRMED THE COMPLAINT. NO ISSUES WERE IDENTIFIED ON THE RETURNED CASSETTE. A LEAK WAS IDENTIFIED ON THE RETURNED PUMP.

    Additional Manufacturer Narrative · 0

    A.4 IS UNKNOWN. THE PURGE CASSETTE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    DURING SUPPORT OF AN IMPELLA 5.5 LOW PURGE PRESSURE AND A PURGE LEAK OCCURRED. THE PURGE WAS LEAKING BETWEEN THE PURGE RETAINER, DISC AND FILTER. THERE WAS A SUSTAINED PURGE PRESSURE LOW ALARM WITH FLUID DRIPPING ONTO THE FLOOR. ALL CONNECTION POINTS WERE CHECKED AND WERE TIGHT. LATER, THE PUMP WAS EXPLANTED. THIS IS ONE OF TWO REPORTS. THIS REPORT REPRESENTS THE PURGE CASSETTE. ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE PUMP. REFER TO SECTION H.10 FOR THE RELATED REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317803 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 45 YR Male