BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PC GEN 2, NON-QSK, STERILE

    MDR report key: 23964351 · Received January 5, 2026

    Report

    Report Number
    1220648-2026-00134
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    November 16, 2025
    Report Date
    February 13, 2026
    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

    THE FOLLOWING SECTION HAS BEEN CHANGED: H6 MED DEV PROB CODE CHANGED FROM A141101 (DECREASE IN PRESSURE) TO A050401 (FLUID/BLOOD) LEAK.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 71-YEAR-OLD MALE PATIENT WHOSE PURGE SYSTEM PURGE PRESSURE TRANSMITTER WAS NOTED TO BE LEAKING FLUID FROM THE MEMBRANE FILTER DURING TRANSPORT FROM (B)(6). THE COMPONENT WAS REPLACED. NO DETAILED INFORMATION WAS AVAILABLE REGARDING WHETHER ANY ALARMS OCCURRED WHILE OPERATING WITH THE REPLACEMENT UNIT. A REQUEST FOR CORRECTIVE ACTION REGARDING THE DEFECT WAS MADE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27753 PC GEN 2, NON-QSK, STERILE TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PC GEN 2, NON-QSK, STERILE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male