BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER

    MDR report key: 33334 · Received May 2, 1996

    Report

    Report Number
    2243621-1996-00119
    Event Type
    Injury
    Date Received
    May 2, 1996
    Date of Event
    February 23, 1996
    Report Date
    April 30, 1996
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FJI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING HEMODIALYSIS TREATMENT EXPERIENCED EPIGASTRIC PAIN AND DISCOMFORT AT END OF 3.5 HR TREATMENT. BLOOD PRESSURE ALSO ELEVATED TO 222/125. PORCANTIC 10 MGS SL GIVEN. PT DISCHARGED TO HOME. LATER THAT EVENING PT ADMITTED TO THE HOSP WITH HEMOLYSIS. PT ALSO EXPERIENCED PANCREATITIS WHILE HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER DIALYZER FJI BAXTER HEALTHCARE CORP. CF25 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R