BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS

    MDR report key: 279383 · Received May 23, 2000

    Report

    Report Number
    279383
    Event Type
    Injury
    Date Received
    May 23, 2000
    Date of Event
    April 7, 2000
    Report Date
    May 16, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWENTY MINUTES INTO HEMODIALYSIS TREATMENT, VENOUS BLOODLINE BECAME DISCONNECTED FROM PERM CATH. PT CALLED WHEN FELT WET. PT PLACED IN "T-BERG" POSITION ON THE LEFT SIDE, LINES CLAMPED, SALINE FLUSHES TO CATHETER, PT MONITORED CLOSELY, WAS STABLE, WAS RETURNED TO DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS BLOODLINE FKJ FRESENIUS MEDICAL CARE 03-7303-5 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 1. ASH-SPLIT PERM CATH,| 3. FRESENIUS F-8 DIALYZER.| 2. FRESENIUS 2008-H MACHINE,