BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER 550

    MDR report key: 85288 · Received July 2, 1996

    Report

    Report Number
    85288
    Event Type
    Injury
    Date Received
    July 2, 1996
    Date of Event
    December 29, 1995
    Report Date
    April 30, 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 DEVELOPED NAUSEA AND VAGUE GI COMPLAINTS DURING HEMODIALYSIS TREATMENT. TREATED WITH PHENERGAN 12.5MGS IV. DISCHARGED TO HOME. PT LATER PRESENTED AT HOSP. HEMOLYSIS WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER 550 HEMODIALYSIS MACHINE FII * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| O| R NMC ARTERIAL REUSE LINE| TERUMO T 175