BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCHEM

    MDR report key: 21960765 · Received May 5, 2025

    Report

    Report Number
    21960765
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    October 2, 2024
    Report Date
    April 29, 2025
    Manufacturer
    THERMASOLUTIONS, INC.
    Product Code
    MLW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HIPEC [HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY] PERFUSION MACHINE WAS DISCOVERED TO BE INOPERABLE BY PERFUSIONIST WHEN SETTING UP MACHINE IN OR [OPERATING ROOM]. PATIENT WAS INTUBATED AND PREPPED WHEN DISCOVERED AND AFTER DISCUSSION WITH PHYSICIAN THE CASE WAS CANCELLED DUE TO NOT HAVING NECESSARY EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513048 THERMOCHEM WARMER, PERITONEAL DIALYSATE MLW THERMASOLUTIONS, INC. HT-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male