BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIC SOLUTION SET

    MDR report key: 200643 · Received December 2, 1998

    Report

    Report Number
    6000001-1998-00732
    Event Type
    Malfunction
    Date Received
    December 2, 1998
    Date of Event
    November 1, 1998
    Report Date
    November 23, 1998
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED IN WHICH LEAKAGE IS OCCURRING FROM AROUND THE FILTER. RPTR STATED THEY NOTICED THE FILTER WAS LEAKING DUE TO THE HOMECARE PT'S BED BEING WET. REPORTED DEVICE BEING UTILIZED ON A FLO-GARD PUMP, WITH INFUSION SET AT 100-125 CC/HR. THREE INCIDENTS, PT'S WIFE STATED THERE WAS NO COMPROMISE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIC SOLUTION SET BASIC SET FPA BAXTER HEALTHCARE CORPORATION NA Z217141R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN