BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    MDR report key: 23215980 · Received October 3, 2025

    Report

    Report Number
    1220648-2025-47160
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 3, 2025
    Report Date
    January 23, 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

    D9 UPDATED. H6 UPDATED. THIS MDR FOR THE PURGE CASSETTE IS BEING RETRACTED THE PURGE PRESSURE LOW ISSUE WAS RELATED TO THE PUMP.

    Additional Manufacturer Narrative · 0

    D4: LOT INFORMATION AND PRIMARY UDI NUMBER IS UNKNOWN. THE RELATED PUMP IS REPORTED UNDER SEPARATE MDR REPORT.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. A PURGE PRESSURE LOW ALARM OCCURRED IMMEDIATELY AFTER THE PUMP STARTED. PURGE FLOW RATE 30ML/H, PURGE PRESSURE 170-250. THERE WERE NO PROBLEMS WITH THE PURGE HOUSING CONNECTION, AND RE-PRIMING AFTER BLEEDING THE AIR DID NOT IMPROVE THE SITUATION. THE PROBLEM CONTINUED EVEN AFTER REPLACING THE PURGE SET WITH A NEW ONE, AND EVEN AFTER CHANGING THE GLUCOSE SOLUTION FROM 5% TO 10%, THE PURGE PRESSURE REMAINED AT 200-280 AND THE ALARM CONTINUED. EVEN AFTER REPLACING THE AUTOMATED IMPELLA CONTROLLER , THE PURGE PRESSURE LOW ALARM OCCURRED. THEY SAID THAT THE PURGE SOLUTION WOULD BE RETURNED TO 5% BECAUSE THE PATIENT WAS BECOMING HYPERGLYCEMIC. THE PURGE CASSETTE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253994 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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male