BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX LR CAPILLARY DIALYZER

    MDR report key: 1023447 · Received April 1, 2008

    Report

    Report Number
    9611369-2008-00210
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 7, 2008
    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 THIS SPECIFIC EVENT, AND THE CASE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING THE TREATMENT. THERE WAS A BLOOD LOSS AND THE AMOUNT WAS AROUND 10-15ML. NO PT HARM ANO MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX LR CAPILLARY DIALYZER MSF GAMBRO DIALYSATOREN GMBH POLYFLUX 8 LR 7-8702-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other