BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CONTINU-FLO SOLUTION SET

    MDR report key: 184960 · Received August 26, 1998

    Report

    Report Number
    6000001-1998-00552
    Event Type
    Malfunction
    Date Received
    August 26, 1998
    Date of Event
    August 1, 1998
    Report Date
    August 7, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE OCCURRENCE OF A SET WITH A LEAKING FILTER ON EACH OF TWO CONSECUTIVE DAYS. THE SETS WERE BEING USED FOR THE ADMINISTRATION OF CHEMOTHERAPY. 08/07/1998, CWF NO PATIENT COMPROMISE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO SOLUTION SET CONTINU-FLO SET FPA BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN