BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F6 DIALYZER FINISHED ASSY (CASE)

    MDR report key: 1791393 · Received August 6, 2010

    Report

    Report Number
    1713747-2010-00027
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 6, 2010
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    MSE
    PMA / PMN Number
    K970700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REGARDING AN EVENT WHICH OCCURRED FROM A HEMODIALYSIS USER FACILITY. REPORTEDLY, THE PT HAD BEEN RECEIVING DIALYSIS TREATMENT WHEN AN INTERNAL BLOOD LEAK WAS DETECTED. THE LEAK WAS REPORTED AS ¿GROSS¿ IN THAT VISIBLE BLOOD COULD BE SEEN ENTERING THE DIALYSATE. THERE WAS AN APPROXIMATE 157 ML OF BLOOD LOSS SINCE NO BLOOD WAS RETURNED TO THE PT. THE PT REQUIRED NO MEDICAL INTERVENTION; HOWEVER, A BLOOD TRANSFUSION WAS CONSIDERED. THE FACILITY WAS CONTACTED REGARDING THIS EVENT. IT WAS LEARNED THAT THE PT IS FINE WITH NO ILL EFFECT. ALSO, NO FURTHER INFO WILL BE RELEASED. A COMPANION SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F6 DIALYZER FINISHED ASSY (CASE) DIALYZER MSE OGDEN MANUFACTURING NA 10AU03015

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR GAMBRO PHOENIX DIALYSIS MACHINE