BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 5466468 · Received February 29, 2016

    Report

    Report Number
    3006158088-2016-00002
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    February 11, 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). THE CASSETTE (LOT 231124453) WAS MANUFACTURED IN 2012. SINCE THAT TIME, CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO REDUCE THE OCCURRENCE OF LEAKING AT INTERNAL BOND. COMPLAINTS BASED ON BONDING/LENGTH ISSUES IN THIS AREA OF THE CASSETTE HAVE NOT BEEN SEEN IN RECENT CASSETTE LOTS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE THERMACOR 1200 INFUSION SYSTEM WAS BEING USED AT (B)(6). THE HOSPITAL REPORTED THE CASSETTE WAS LEAKING FROM THE BOTTOM OF THE CASSETTE. THE HOSPITAL CONTINUED TO USE THE CASSETTE UNTIL THE PRESSURE ERROR OCCURRED - PATIENT LINE BLOCK. THE ERROR MESSAGE WOULD NOT CLEAR, AND THE OPERATOR HAD TO MANUAL SQUEEZE THE BAG. THE HOSPITAL HAD DEPLETED INVENTORY AND DID NOT HAVE A CASSETTE FOR REPLACEMENT. THE HOSPITAL DID NOT RETURN THE CASSETTE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125169 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PTC-1200 231124453

    Patients

    Seq Age Sex Outcome Treatment
    1