BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 3921344 · Received May 21, 2014

    Report

    Report Number
    3006158088-2014-00001
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 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) UNIV ON (B)(6) 2014. AT THE END OF THE CASE AFTER EIGHT UNITS OF BLOOD HAD ALREADY BEEN INFUSED, THE PATIENT LINE (LOT 331128477) BEGAN TO LEAK. THE HOSPITAL INDICATED THEY THOUGHT IT WAS A PUMP ISSUE. THE THERMACOR 1200 UNIT ((B)(4)) WAS RETURNED FOR TESTING. INITIAL TESTING OF THE UNIT INDICATED THE UNIT WAS NOT DETECTING PRESSURE. THE PRESSURE INCREASE CAUSED THE PATIENT LINE TO LEAK. THE UNIT WAS SENT TO THE MANUFACTURER FOR REPAIR. IT WAS DETERMINED THAT THE UNIT HAD BEEN DAMAGED BY THE END USER. THE DAMAGED PRESSURE PORTS AND HOUSING WERE REPLACED. THIS DAMAGE TO THE UNIT WAS POSSIBLY CAUSED BY THE UNIT BEING TIPPED OVER OR SOMETHING HITTING THE PRESSURE PORT AREA. NO PATIENT ISSUE OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303494 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM LGZ SMISSON-CARTLEDGE BIOMEDICAL LLC TIS-1200

    Patients

    Seq Age Sex Outcome Treatment
    1