BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 5479940 · Received March 4, 2016

    Report

    Report Number
    3006158088-2016-00003
    Event Type
    Malfunction
    Date Received
    March 4, 2016
    Date of Event
    February 8, 2016
    Report Date
    February 12, 2016
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K052055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE THERMACOR 1200 INFUSION SYSTEM WAS BEING USED AT THE MEDICAL CENTER OF (B)(6). THE HOSPITAL REPORTED WHILE TRANSPORTING A PATIENT TO THE O.R, THE THERMACOR UNIT WAS BEING PRIMED AND A SALINE LEAK OCCURRED AT THE BOTTOM OF THE CASSETTE. NO VISUAL CRACKS OR DAMAGE WERE NOTED WITH THE CASSETTE. THE CASSETTE WAS CHANGED OUT AND RE-PRIMED. THE UNIT CONTINUED TO PERFORM UNTIL BLOOD WAS ADDED; THE PATIENT LINE DISCONNECTED AND LEAKED BLOOD. THE NURSE HELD THE LINE TOGETHER UNTIL A FEW PINTS WERE ADMINISTERED; THE REMAINING OF THE BLOOD WAS ADMINISTERED MANUALLY. THE PATIENT WAS TRANSPORTED TO THE OR; THE THERMACOR UNIT WAS NOT USED DURING SURGERY. THE HOSPITAL DID NOT RETURN THE CASSETTES FOR FURTHER INVESTIGATION; HOWEVER THE UNIT WAS RETURNED FOR TESTING. TESTING WAS COMPLETED ON (B)(6) 2016, AND IT WAS FOUND THAT THE THERMACOR UNIT HAD BEEN BROKEN AND DAMAGED BY THE HOSPITAL. DUE TO THE DAMAGE, THE PUMP COULD NOT DETECT PRESSURE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137813 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC TIS-1200

    Patients

    Seq Age Sex Outcome Treatment
    1