BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-TEMP

    MDR report key: 1942348 · Received December 22, 2010

    Report

    Report Number
    1313850-2010-00011
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    January 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    KZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO CONTAMINATION, DEVICE UNABLE TO BE RETURNED TO MFR FOR INVESTIGATION. NO CONCLUSION REGARDING CAUSE OF THE MALFUNCTION CAN BE DRAWN AT THIS TIME. USER FACILITY WAS CONTACTED TO REVIEW OPERATORS MANUAL CLEANING INSTRUCTIONS AND USE OF DEVICE. THE DEVICE'S ELECTRONICS ARE SEALED FROM FLUID INGRESS. THE DEVICE IS IPX 4 RATED.

    Description of Event or Problem · 1

    A BLOOD/FLUID WARMER, MODEL FW600, WAS REPORTED BY CUSTOMER TO HAVE BLOOD CONTAMINATION THAT RENDERED IT UNUSABLE. THE HOSPITAL TRIED CLEANING AND DECONTAMINATING THE UNIT, BUT THE BLOOD HAD LEAKED INTO THE ELECTRONICS OF THE UNIT AND COULD NOT COMPLETELY BE REMOVED. WITH THE BLOOD CONTAMINATION, THE UNIT COULD NOT BE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TEMP KZL GAYMAR INDUSTRIES, INC. FW600

    Patients

    Seq Age Sex Outcome Treatment
    1