BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 3871207 · Received April 16, 2014

    Report

    Report Number
    3006158088-2014-00006
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 16, 2014
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL LLC
    Product Code
    LGZ
    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 INFUSION SYSTEM WAS BEING USED AT (B)(6) HOSP ON (B)(6) 2014. DURING THE SURGERY, IT WAS NOTICED THAT THE 3 SPIKE SET (TSS-1200), AN ACCESSORY FOR THE PUMP, WAS LEAKING AT THE BOTTOM OF THE CHAMBER. THE TUBING SET WAS REPLACED WITH A SECOND SET FROM THE SAME LOT WITH NO ISSUES NOTED WITH THE SECOND TUBING SET. THE 3 SPIKE SET WAS UNAVAILABLE FOR REVIEW. NO ADD'L TIME TO SURGERY WAS NOTED DUE TO THE CHANGE OF THE 3 SPIKE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233581 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM - LGZ, FRN LGZ SMISSON-CARTLEDGE BIOMEDICAL LLC TSS-1200 331128113

    Patients

    Seq Age Sex Outcome Treatment
    1