BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX S CAPILLARY DIALYZER

    MDR report key: 934117 · Received April 11, 2007

    Report

    Report Number
    9611369-2007-00142
    Event Type
    Malfunction
    Date Received
    April 11, 2007
    Report Date
    March 12, 2007
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K982414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS BLOOD LEAK DURING TREATMENT. IT OCCURRED RIGHT AFTER CONNECTION TO THE PATIENT. TREATMENT PARAMETERS: BFR: 250ML/MLN, DFR: 500ML/MLN. THE BLOOD LOSS FOR THE PATIENT WAS MINIMAL AND NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX S CAPILLARY DIALYZER KDI KDI GAMBRO DIALYSATOREN GMBH POLYFLUX 14 S 6-2518-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other AK 95 S