BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 20762092 · Received November 22, 2024

    Report

    Report Number
    3006158088-2024-00001
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 22, 2024
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00857893006110
    PMA / PMN Number
    K202461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE THERMACOR 1200 RAPID INFUSION SYSTEM WAS BEING USED AT (B)(6) MEDICAL CENTER ON (B)(6) 2024, AND DURING A PROCEDURE, THE HOSPITAL STATED THE RETURN LINE ON THE 3 SPIKE SET DETACHED AND CAUSED BLOOD TO LEAK AT THE LINE CONNECTION. THE SET WAS REPLACED AND THE SURGERY CONTINUED. NO PATIENT INJURY OR EXTENDED TIME TO SURGERY WAS NOTED BY THE HOSPITAL. THE DHR WAS REVIEWED, AND NO ISSUE WAS NOTED DURING ASSEMBLY OR DURING LEAK TESTING. THE 3 SPIKE SET WAS RETURNED BY THE HOSPITAL, AND THE INVESTIGATION WAS COMPLETED. THE RETURNED 3 SPIKE SET CONNECTIONS WERE CHECKED AND VERIFIED TO MEET SPECIFICATIONS. DURING THE INSPECTION, IT WAS NOTED THAT THE ONE-WAY VALVE THAT THE BARB IS ATTACHED TO WAS PLACED PROPERLY AND THERE WERE NO ISSUES NOTED WITH THE VALVE. IT WAS INSTALLED CORRECTLY, AND 15PSI OF AIR WAS SENT THROUGH IT. WHEN AIR WAS SENT IN THE OTHER DIRECTION, THE VALVE SHUT AND BLOCKED THE AIR ACCESS AS IT SHOULD. THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. THE RETAIN SAMPLE WAS OPENED, AND THE RETURN LINE CONNECTION WAS SECURE. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES WITH THE 3 SPIKE SETS IN THE FIELD. THERE IS NO INVENTORY LEFT AVAILABLE FOR THIS LOT OF CASSETTES. IT WAS NOTED THAT THIS WAS A USER ERROR IN HANDLING OF THE 3 SPIKE SET. IT IS VERY LIKELY THAT THE NURSE/OPERATOR HELD ONTO THE TUBE WHILE UNSCREWING THE LUER INSTEAD OF HOLDING ONTO THE LUER'S GROOVES TO UNSCREW. ADDITIONAL TRAINING WILL BE CONDUCTED TO ENSURE PROPER HANDLING AND USAGE OF THE CASSETTE AND 3 SPIKE SETS ARE PERFORMED CORRECTLY BY THE HOSPITAL PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799061 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PTC-1200 08139-060624 00857893006110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown