BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PC GEN 2, NON-QSK, STERILE, JAPAN

    MDR report key: 23524580 · Received November 11, 2025

    Report

    Report Number
    1220648-2025-48272
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    August 5, 2025
    Report Date
    November 11, 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

    NO PRODUCT OR DATA LOGS WERE RETURNED FOR EVALUATION. THE CAUSE OF THE PURGE PRESSURE LOW ALARMS COULD NOT BE DETERMINED AS NO PRODUCT OR DATA LOGS WERE RETURNED FOR EVALUATION AND LIMITED CLINICAL DETAILS WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE IMPELLA DEVICE WAS DISCARDED BY 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LOW PURGE FLOW ALARM AND AN INTRAVENTRICULAR ALARM OCCURRED DURING SUPPORT OF AN IMPELLA CP. THE PURGE CASSETTE WAS REPLACED AND HEPARIN WAS ADDED TO THE PURGE TO CLEAR THE PURGE FLOW ALARM. THE PUMP POSITION WAS CONFIRMED TO BE CORRECT BUT THE INTRAVENTRICULAR ALARM DID NOT CLEAR. LATER, THE PATIENT WAS SUCCESSFULLY WEANED FROM THE PUMP AND SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593217 PC GEN 2, NON-QSK, STERILE, JAPAN TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PC GEN 2, NON-QSK, STERILE, JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male