BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX LR CAPILLARY DIALYZER

    MDR report key: 1033476 · Received April 23, 2008

    Report

    Report Number
    9611369-2008-00318
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 15, 2008
    Report Date
    March 28, 2008
    Manufacturer
    GAMBRO DIAYLZATOREN GMBH
    Product Code
    MSF
    PMA / PMN Number
    K023615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MFR NARRATIVE. NO FAILURE WAS FOUND DURING INVESTIGATION. GAMBRO DOES NOT REGARD THE SUBMISSION OF THIS REPORT AS AN ADMISSION OF LIABILITY.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. BLOOD FLOW RATE 112ML/MIN. TMP: 120MHG. THERE WAS INSIGNIFICANT BLOOD LOSS. NO MEDICAL INTERVENTION WAS NEEDED. NO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX LR CAPILLARY DIALYZER MSF GAMBRO DIAYLZATOREN GMBH POLYFLUX 6 LR 7-8605-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other