BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX LR CAPILLARY DIALYZER

    MDR report key: 1033479 · Received April 23, 2008

    Report

    Report Number
    9611369-2008-00319
    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. INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE OF THE HOLLOW FIBRES. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT, AND THE CASE IS CONSIDERED CLOSED. 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