BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE, STERILE, NON-QSK

    MDR report key: 24612531 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05388
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    October 24, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRIMING PROBLEMS - THE CAUSE OF THE PRIMING PROBLEMS WAS NOT DETERMINED DUE TO NO DEFECT FOUND WITH RETURNED PC, NO DATA LOGS RECOVERED, AND INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT SUPPORTED WITH AN IMPELLA CP DEVICE AND VENO-VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION EXPERIENCED AN ALARM INDICATING AIR IN THE PURGE LINE. MULTIPLE DE-AIRING PROCEDURES WERE PERFORMED, AND TWO ATTEMPTED PURGE CASSETTE EXCHANGES DID NOT RESOLVE THE ISSUE. THE ALARM WAS ONLY CLEARED AFTER THE PURGE CASSETTE WAS FULLY REPLACED WITH A NEW ONE. THE AUTOMATED CONTROLLER INVOLVED IN THE ISSUE COULD NOT BE CORRECTLY SELECTED IN THE FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665556 PURGE CASSETTE, STERILE, NON-QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP DYB ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male