BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 3994766 · Received June 13, 2014

    Report

    Report Number
    3006158088-2014-00003
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 13, 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) ON (B)(6) 2014. THE HOSPITAL BELIEVES THAT AN OCCLUSION IN THE CATHETER CAUSED THE PATIENT LINE TO COME OFF THE CASSETTE. NO PATIENT OR ADDITIONAL PRODUCT INFORMATION WAS AVAILABLE. THE UNIT WAS TESTED BY THE SALE REPRESENTATIVE, AND HE NOTICED THAT THE UNIT DID NOT SENSE PRESSURE WHEN THE PATIENT LINE WAS CLAMPED. THE UNIT ((B)(4)) WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. IT WAS DETERMINED THAT THE PRESSURE PORT WAS NOT FLUSH WITH THE HOUSING. THIS COULD POSSIBLY BE CAUSED BY DAMAGE TO THE PORT AREA OF THE UNIT .THE HOUSING WAS REPLACED AND THE PORT WAS MOUNTED FLUSH TO THE HOUSING. ACCEPTANCE TESTING WAS PERFORMED ON THE UNIT WITH NO PROBLEMS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350749 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM LGZ SMISSON-CARTLEDGE BIOMEDICAL LLC TIS-1200

    Patients

    Seq Age Sex Outcome Treatment
    1