BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    MDR report key: 23977646 · Received January 6, 2026

    Report

    Report Number
    1220648-2026-00186
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 30, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 MEDICAL DEVICE PROBLEM CODE WAS REVISED TO A1414 AS A141301 WAS ERRONEOUSLY REPORTED ON THE INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    SECTION D CATALOG NUMBER WAS CORRECTED. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D9 WAS UPDATED.

    Additional Manufacturer Narrative · 0

    THE PURGE CASSETTE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DEVICE SET UP IN THE CATHETERIZATION LAB, THE PURGE CASSETTE AND DISC WERE INSERTED FOLLOWING BEST PRACTICES BUT NO PURGE SOLUTION WAS FLOWING THROUGH THE DEVICE. THE PURGE CASSETTE AND DISC WERE REMOVED AND RE-INSERTED INTO AUTOMATED IMPELLA CONTROLLER (AIC) WITHOUT RESOLVE. THE TUBING WAS CHECKED AND NO KINKS WERE NOTED. THE SAME ISSUE OCCURRED WITH THE ACCOUNTS OTHER AIC. THE ISSUE RESOLVED WITH OPENING A NEW PURGE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578929 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 1987870

    Patients

    Seq Age Sex Outcome Treatment
    1