BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 10977945 · Received December 9, 2020

    Report

    Report Number
    3006158088-2020-00008
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 9, 2020
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00857893006059
    PMA / PMN Number
    K052055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE THERMACOR 1200 RAPID INFUSION SYSTEM WAS BEING USED AT (B)(6) ON (B)(6) 2020 FOR A MASS TRANSFUSION PROTOCOL. DURING THE PROCEDURE, THE HOSPITAL STATED THE CASSETTE STARTED LEAKING. THE HOSPITAL CONTINUED THE SURGERY BY USING PRESSURE BAGS, AND A RANGER FLUID WARMER. THE SURGERY WAS COMPLETED WITH NO PATIENT HARM, OR INJURY. NO EXTENDED TIME TO SURGERY WAS NOTED BY THE HOSPITAL. THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD. THE CASSETTE WAS NOT RETURNED BY THE HOSPITAL, WHICH NO FURTHER INVESTIGATION COULD BE PERFORMED ON THE LEAKING CASSETTE. IT IS UNKNOWN AT THIS TIME WHAT CAUSED THE LEAKING. THIS HAS BEEN AN ISOLATED INCIDENT WITH NO OTHER ISSUES NOTED FROM OTHER HOSPITALS FOR THIS LOT OF CASSETTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443211 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PTC-1200 323448 00857893006059

    Patients

    Seq Age Sex Outcome Treatment
    1