BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE FLUID WARMING SET WITH GAS VENT

    MDR report key: 2140389 · Received June 17, 2011

    Report

    Report Number
    2183502-2011-00484
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 15, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPOSABLE DEVELOPED A LEAK THAT ALLOWED THE RECIRCULATING SOLUTION TO MIX WITH THE INFUSATE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 HOTLINE FLUID WARMING SET WITH GAS VENT LGZ - WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC. NA 1952640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA