BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE, STERILE, NON-QSK

    MDR report key: 24315698 · Received February 11, 2026

    Report

    Report Number
    1220648-2026-02902
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    February 5, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A AND D6B: ADDED IMPLANT AND EXPLANT DATES.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO DOCUMENT THAT THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. SECTION D9 HAS BEEN UPDATED TO REFLECT THAT THE PRODUCT WAS RETURNED FOR INVESTIGATION.

    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 MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    FLUID LEAK: THE CAUSE OF THE FLUID LEAK WAS AN INSUFFICIENT SEAL BETWEEN THE PISTON AND CYLINDER HEAD, A KNOWN MANUFACTURING DEFICIENCY WITH PURGE CASSETTE GEN1.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PURGE SYSTEM WAS LEAKING. THE CUSTOMER EXCHANGED THE PURGE SYSTEM. THIS IMPELLA CASSETTE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA RP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245931 PURGE CASSETTE, STERILE, NON-QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 LOT 1880272

    Patients

    Seq Age Sex Outcome Treatment
    1