BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIPEC PUMP

    MDR report key: 23542589 · Received November 13, 2025

    Report

    Report Number
    23542589
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 10, 2025
    Product Code
    MLW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS SCHEDULED FOR CYTOREDUCTIVE SURGERY AND HIPEC [HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY] TREATMENT. CHEMOTHERAPY STARTED AT 12. 25 PM. THE OUTFLOW DURING THE TREATMENT WAS LOW AND PROVIDER WAS CALLED BACK TO THE ROOM. PROVIDER SCRUBBED IN AND MANIPULATED THE TUBE AND TROUBLESHOOTED. HE NOTICED THE INFLOW WAS NOT CIRCULATING WELL AT THE PUMP AND WE CALLED THE REP. REP TRIED TO TROUBLE SHOOT AND NOT WORKED WELL. SECOND BAG OF CHEMO STARTED AT 75 MINUTES. THE MACHINE WAS PULLED OUT FOR INSPECTION. COMPANY SERVICE PERSON IS CALLED TO SERVICE THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195629 HIPEC PUMP WARMER, PERITONEAL DIALYSATE MLW

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female