BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NMC BLOODLINE

    MDR report key: 60239 · Received July 2, 1996

    Report

    Report Number
    60239
    Event Type
    Injury
    Date Received
    July 2, 1996
    Date of Event
    February 16, 1996
    Report Date
    June 24, 1996
    Manufacturer
    *
    Product Code
    FJK
    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 BELOW 90/40. 500 CC 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 NMC BLOODLINE ARTERIAL BLOODLINE FJK * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization VENOUS BLOODLINE 037303-5| FRESENIUS 2008H MACHINE, FRESENIUS F8 DIALYZER NMC