BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER

    MDR report key: 85117 · Received July 2, 1996

    Report

    Report Number
    85117
    Event Type
    Injury
    Date Received
    July 2, 1996
    Date of Event
    May 20, 1996
    Report Date
    June 7, 1996
    Manufacturer
    *
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED 3 HOURS AND 45 MINUTES HEMODIALYSIS TREATMENT. DISCHARGED TO HOME WITHOUT COMPLAINT. FACILITY RECEIVED PHONE CALL FROM PTS WIFE. PT FELT NAUSEATED. RETURNED TO FACILITY FOR EVALUATION AND THEN SENT TO HOSP. HEMALYSIS WAS IDENTIFIED. LDH WAS FOUND TO BE 5,000. DURING TREATMENT VENOUS PRESSURE DROPPED FROM 240 START TO 150 AT END. DURING HOSPITALIZATION 4 UNITS OF BLOOD WERE TRANSFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER 550 UF HEMODIALYSIS MA. FII * * 77340

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization NMC BLOOD LINES 03-9608-5 ART.| 03-7303-5 VEN. F8 DIALYZER