BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS

    MDR report key: 60266 · Received July 2, 1996

    Report

    Report Number
    60266
    Event Type
    Injury
    Date Received
    July 2, 1996
    Date of Event
    February 16, 1996
    Report Date
    June 24, 1996
    Manufacturer
    FRESENIUS
    Product Code
    FDI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPROX 1/2 WAY THROUGH A 4 HR HEMODIALYSIS TREATMENT THE PT C/O NOT FEELING WELL. BP 90/40. 500CC NACL GIVEN. BP 101/50. PT REQUESTED TO GOT TO ER. C/O FEELING BLOATED. ADMITS TO NO BOWEL MOVEMENT FOR 1 WEEK. ALSO, CLOTS ASPIRATED FROM ACCESS PRE-TREATMENT. FLOW OF 400 CC/MIN. VENOUS PRESSURE FLUCTUATING BETWEEN 150-90-140-130-90-180. PT WAS ADMITTED AND HEMOLYSIS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS F-8 FDI FRESENIUS * 89189-44BB

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization 03-7200-3 + 03-7303-5| FRESENIUS 2008H DIALYSIS MACHINE, NMC BLOODLINES