BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAMCOR 1200 RAPID INFUSER

    MDR report key: 11243334 · Received January 27, 2021

    Report

    Report Number
    MW5099043
    Event Type
    Injury
    Date Received
    January 27, 2021
    Date of Event
    January 9, 2021
    Report Date
    January 25, 2021
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERMACOR 1200 RAPID INFUSER BEING USED DURING TRAUMA. DEVICE PROPERLY SET UP FOR USE. WOULD NOT INFUSE ONCE CONNECTED TO PATIENT - CONTINUED TO PROVIDE ERROR MESSAGE "ERROR ON PATIENT SIDE". THE PUMP WAS CONNECTED TO LARGE BORE PERIPHERAL LINE, WHICH WAS UNCLAMPED AND FUNCTIONAL. TROUBLESHOOTING ATTEMPTS BY MULTIPLE STAFF PROVED UNSUCCESSFUL. WHEN DISCONNECTED FROM PATIENT, MACHINE WOULD RUN WITHOUT DIFFICULTY. CHANGED VASCULAR ACCESS SITE AND MOVED INFUSER TO A NEWLY PLACED CORDIS, WHICH PROVIDED SAME ERROR MESSAGE. ADMINISTRATION INITIATED VIA ALTERNATE MECHANISM. UPON TRANSFERRING PT TO A DIFFERENT CARE AREA, A DIFFERENT THERMACOR MACHINE WAS CONNECTED TO LINE AND INFUSION STARTED. HOWEVER, AFTER AN EXTENDED TIME, THIS MACHINE BEGAN TO LEAK BLOOD FROM THE CARTRIDGE. ADMINISTRATION CONTINUED VIA ALTERNATE MECHANISM. THESE INCIDENTS RESULTED IN BLOOD ADMINISTRATION DELAYS TO A PT IN HYPOVOLEMIC SHOCK. VENDOR CAME ON-SITE AFTER THIS MOST RECENT INCIDENT AND TWO DEVICES FAILED AND VENDOR UNABLE TO TROUBLESHOOT FAILURE. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138293 THERAMCOR 1200 RAPID INFUSER PUMP, INFUSION FRN SMISSON-CARTLEDGE BIOMEDICAL LLC
    138294 THERAMCOR 1200 RAPID INFUSER PUMP, INFUSION FRN SMISSON-CARTLEDGE BIOMEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R