BEUDAMED
    FDA Adverse Event Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 4991127 · Received August 11, 2015

    Report

    Report Number
    3006158088-2015-00004
    Date Received
    August 11, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 7, 2015
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    LGZ
    PMA / PMN Number
    K0520055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE THERMACOR 1200 INFUSION SYSTEM WAS BEING USED AT (B)(6). THE HOSPITAL REPORTED THE CASSETTE LEAKING AT THE CONNECTION TO THE PATIENT LINE. THE THERMACOR 1200 UNIT ((B)(4)) WAS RETURNED FOR TESTING, AND THE UNIT WAS WORKING WITHIN SPECIFICATIONS. THE CASSETTE AND PATIENT LINE WERE RETURNED FOR FURTHER INVESTIGATION. THE LEAKAGE WAS CONFIRMED AT THE CASSETTE CONNECTOR BOND WHERE THE PATIENT LINE ATTACHES. THE HOSPITAL WAS ABLE TO COMPLETE THE SURGERY USING THE CASSETTE. THE CASSETTE (LOT 231124596) WAS MANUFACTURED IN FEBRUARY 2012. SINCE THAT TIME, CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ASSURE THE OPERATORS ARE APPLYING ENOUGH ADHESIVE AND ALLOWING THE BONDING TO DRY. COMPLAINTS BASED ON BONDING ISSUES IN THIS AREA OF THE CASSETTE / PATIENT LINE CONNECTIONS HAVE NOT BEEN SEEN IN RECENT CASSETTE LOTS. NO PATIENT INJURY WAS RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527052 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM LGZ SMISSON-CARTLEDGE BIOMEDICAL, LLC PNC-1200 231124596

    Patients

    Seq Age Sex Outcome Treatment
    1