BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMACOR 1200 THERMAL INFUSER SYSTEM

    MDR report key: 9118867 · Received September 24, 2019

    Report

    Report Number
    MW5090032
    Event Type
    Death
    Date Received
    September 24, 2019
    Date of Event
    September 8, 2019
    Report Date
    September 9, 2019
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FOR REPORT MW5090032. CALLER CALLED TO UPDATE PT'S CONDITION AS DECEASED AND THAT THE THERMACOR DEVICE DID NOT CONTRIBUTE TO THE PT'S DEATH.

    Description of Event or Problem · 1

    THERMACOR RAPID INFUSER BEGAN TO REPEATEDLY SHOW AN ERROR STATING "OVERHEATED - TURN OFF AND ON." THIS REQUIRED CONSTANT PAUSES IN THE RAPID INFUSING OF BLOOD PRODUCTS TO A CRITICAL PT. IT WAS UNPLUGGED, THEREFORE THE HEATING MECHANISM WAS NOT IN USE. WE TRIED PLUGGING THE MACHINE IN SO THAT IT WOULD NOT BE USING BATTERY POWER, BUT THE ERROR MESSAGE CONTINUED. VENDOR - SENT THE SUPPLIES (CONTAINED OLDER VERSION OF THE FILTER WE WERE NOT EDUCATED ON (TUBING / FILTER FOR NEW THERMACOR 1200). ADD'L PROBLEM IDENTIFIED - THE PACKAGING FOR THE TUBING / FILTERS MENTIONED ABOVE HAVE THE SAME PACKAGING AND PRODUCT NUMBERS. EQUIPMENT MALFUNCTION - CLIP BROKE OFF. MANUAL PROCESS USED BY STAFF TO PREVENT PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902806 THERMACOR 1200 THERMAL INFUSER SYSTEM WARMER, THERMAL, INFUSION FLUID LGZ SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200
    902807 THERMACOR 1200 THERMAL INFUSER SYSTEM WARMER, THERMAL, INFUSION FLUID LGZ SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death