BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX LR CAPILARY DIALYZER

    MDR report key: 959526 · Received December 7, 2007

    Report

    Report Number
    9611369-2007-00593
    Event Type
    Malfunction
    Date Received
    December 7, 2007
    Date of Event
    November 13, 2007
    Report Date
    November 20, 2007
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MSF
    PMA / PMN Number
    K023615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO IS EXPECTED FOR THE SPECIFIC EVENT, AND THE CASE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS BLOOD LEAK DURING TREATMENT. BLOOD FLOW RATE 240ML/MLN, TMP, 120 MMHG. THE BLOOD LOSS WAS ABOUT 5ML. NO PT HARM AND NO MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX LR CAPILARY DIALYZER MSF GAMBRO DIALYSATOREN GMBH POLYFLUX 6 LR 7-9700-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Other MACHINE: AK-2006