BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIALOG

    MDR report key: 1213687 · Received October 24, 2008

    Report

    Report Number
    2523676-2008-00087
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 20, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K963440
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MACHINE WAS FUNCTIONALLY CHECKED BY THE FACILITIES TECHNICIAN. IT HAS BEEN DETERMINED THE MACHINE FUNCTIONED PROPERLY AND WAS NOT RELATED TO THE INCIDENT REPORTED. IT APPEARS THE INCIDENT WAS MOST LIKELY RELATED TO THE PLACEMENT OF A NEW FISTULA. HOWEVER, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE MACHINE HAS BEEN BACK IN OPERATION SINCE THE REPORTED INCIDENT WITH NO PROBLEMS. THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE AGAINST THIS MACHINE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PT RAN 3 HOUR THERAPY, WITHOUT THERAPY RELATED PROBLEMS. PT LEFT FACILITY AND REPORTED BLOOD IN URINE. AS REPORTED BY CUSTOMER, PT LATER WENT TO HOSPITAL THE SAME DAY AND IS CURRENTLY BEING MONITORED. PT WAS DIAGNOSED WITH HEMOLYSIS AND IS CURRENTLY IN THE HOSPITAL. CUSTOMER REPORTED THAT (9) TREATMENTS HAVE BEEN RUN ON SAME MACHINE SINCE THEY REPORTED THIS INCIDENT, WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE PT IS FINE AND THAT THE INCIDENT WAS NOT MACHINE RELATED. THE FACILITY CHECKED WITH THREE OTHER CLINICS THAT HAD THE SAME TYPE OF PROBLEM. IT APPEARS ALL THE PT'S AFFECTED HAD NEW FISTULA'S AND THAT THEY BELIEVE THAT IT HAD SOMETHING TO DO WITH THE PLACEMENT OF THE FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALOG HEMODIALYSIS SYSTEM KDI B. BRAUN MEDICAL, INC. NA 5003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other