BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS BLOODLINE FOR FRESENIUS 2008

    MDR report key: 287077 · Received July 19, 2000

    Report

    Report Number
    8030665-2000-00241
    Event Type
    Malfunction
    Date Received
    July 19, 2000
    Date of Event
    June 20, 2000
    Report Date
    July 19, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED "ONE HOUR INTO TREATMENT BLOOD LINE DISCONNECTED FROM CATHETER". CATHETER IN PLACE APPROXIMATELY 3 MONTHS. ESTIMATED BLOOD LOSS 50CC. NO MEDICAL INTERVENTION. SAMPLE IS NOT AVAILABLE FOR EXAMINATION. MEDWATCH FILED ON THE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE FOR FRESENIUS 2008 DIALYSIS VENOUS BLOODLINE FKJ ERIKA DE REYNOSA NA 0DR140

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Other MEDCOMP CATHETER