BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD LINE

    MDR report key: 10706 · Received December 29, 1993

    Report

    Report Number
    MW1000249
    Event Type
    Injury
    Date Received
    December 29, 1993
    Date of Event
    September 25, 1993
    Report Date
    December 15, 1993
    Manufacturer
    MEDISYSTEMS
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 9/25/93, PT ON CHRONIC DIALYSIS TREATMENT DIALYZER C121, REUSE #16, 3K+ BATH, 15 GA FISTULA NEEDLES. PREDIALYSIS BP 166/100S-88-99.4. WT 76.2 KG. ACCESS IS A LEFT FISTULA. BFR AT 350 ART PRESSURE -40 AND VENOUS PRESSURE 50 AT START OF DIALYSIS. FIFTY MINS INTO THE RUN, PT COMPLAINED OF CHEST PAIN. 02 APPLIED. 35 MINS LATER CHEST PAIN UNRELIEVED BP INCREASED TO 200/104 ART P-30, VENOUS PRESSURE 30. PT NAUSEATED, ABDOMINAL PAIN. PT TAKEN OFF DIALYSIS EARLY, TRANSPORTED AND ADMITTED TO HOSP. HOSP DIALYSIS TREATEMTNE 9/27/93 COMPLAINED OF SORE STOMACH AND CHEST PAIN. PREDIALYSIS PRESSURE 162/90 60 994 ART PRESS-180, VR PRESS 180. UNEVENTFUL RUN. DISCHARGED 9/28/93 PREDIALYSIS BP 170/100 100-986. ART PRESSURE-190 VR 190 F10 AT START OF DIALYSIS DIALYZER C121 REUSE #17-UNEVENTFUL RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD LINE FJK MEDISYSTEMS M3-9605/9705

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization