BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    MDR report key: 23354303 · Received October 21, 2025

    Report

    Report Number
    1220648-2025-47659
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 21, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 ADDED INITIAL REPORTER PHONE NUMBER AND ZIP CODE EXTENSION AS THEY WERE OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. E4 ADDED SELECTION AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. INVESTIGATION SUMMARY: THE INVESTIGATION HAS BEEN COMPLETED. NO PRODUCT WAS RETURNED. PURGE PRESSURE LOW - AFTER TWO DAYS ON SUPPORT, LOW PURGE PRESSURE AND ELEVATED PURGE FLOWS AFTER PURGE BAG EXCHANGE THIS MORNING WERE NOTED. THE ISSUE RESOLVED WITH PURGE CASSETTE CHANGE. THE CAUSE OF THE PURGE PRESSURE LOW WAS NOT DETERMINED AS NO PRODUCT WAS RETURNED AND INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS THE PURGE CASSETTE SERIAL NUMBER AND LOT NUMBER ARE NOT KNOWN.

    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 THAT THEY ENCOUNTERED LOW PURGE PRESSURE DURING IMPELLA CP SUPPORT. LOW PURGE PRESSURE AND ELEVATED PURGE FLOWS WERE ENCOUNTERED AFTER PURGE BAG WAS EXCHANGED. A WALK THROUGH OF A PURGE CASSETTE CHANGE WAS EXPLAINED TO THE BEDSIDE NURSE, WHICH RESULTED IN GAINING BACK BASELINE PURGE FLOWS AND PRESSURES. THERE WERE NO OTHER IMPELLA RELATED ISSUES OR CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446421 PURGE CASSETTE GEN 2, STERILE, NON QSK EMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP DYB ABIOMED, INC. PURGE CASSETTE GEN 2, STERILE, NON QSK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male