BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 4934725 · Received July 21, 2015

    Report

    Report Number
    3006158088-2015-00003
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 30, 2015
    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

    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) MEDICAL CENTER IN (B)(6). THE HOSPITAL REPORTED EXPERIENCING "LIMITED FLOWS" FROM THE PATIENT LINE, WHICH RESULTED IN LEAKAGE. THE THERMACOR 1200 UNIT (1440-00062) WAS RETURNED FOR TESTING, AND THE UNIT WAS WORKING WITHIN SPECIFICATIONS. THE CASSETTE AND PATIENT LINE WERE NOT RETURNED FOR FURTHER INVESTIGATION. HOWEVER, THE SALES REP IN SERVICED THE HOSPITAL STAFF AND OBSERVED THE TYPES OF CATHETERS BEING USED FOR SURGERY. IT WAS NOTED THAT THE HOSPITAL WAS USING TWO TYPES OF CATHETERS - 24-27 GAUGE CATHETERS. A SAMPLE CASSETTE WAS RETURNED TO MEDICAL SOLUTIONS, INC. ALONG WITH TWO CATHETERS. PRESSURE INCREASE WAS VERIFIED WHILE USING THE SMALLER CATHETERS; HOWEVER, NO LEAKAGE OCCURED. RECOMMENDATIONS WERE PROVIDED TO THE HOSPITAL BASED ON THE FINDINGS. THE SMALLER CATHETER SIZES USED WILL SIGNIFICANTLY RESTRICT THE MAXIMUM ACHIEVABLE FLOW RATE AND USING A LARGER SIZE IS RECOMMENDED. THE USER SELECTED PRESSURE AND FLUID BEING DELIVERED WILL ALSO IMPACT FLOW RATE. NO PATIENT INJURY WAS RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471807 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM LGZ SMISSON-CARTLEDGE BIOMEDICAL LLC PTC-1200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1