BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS HOLLOW FIBER DIALYZER

    MDR report key: 289705 · Received August 15, 2000

    Report

    Report Number
    9681863-2000-00001
    Event Type
    Injury
    Date Received
    August 15, 2000
    Date of Event
    July 17, 2000
    Report Date
    August 15, 2000
    Manufacturer
    SECON, ZNL DER GAMBRO / DIALYSATOREN GMBH&CO.KG
    Product Code
    FJI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REACTION 4 MINUTES INTO DIALYSIS TREATMENT. PT LOST CONSCIOUSNESS AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS HOLLOW FIBER DIALYZER HOLLOW FIBER DIALYZER FJI SECON, ZNL DER GAMBRO / DIALYSATOREN GMBH&CO.KG NA G06E5073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention