BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO

    MDR report key: 6215450 · Received December 30, 2016

    Report

    Report Number
    6215450
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 15, 2016
    Report Date
    December 27, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE IV TUBING CHAMBER FILLED WITH MEDICATION, BUT IT WOULD NOT FLOW THROUGH PRIMARY TUBING. MANUFACTURER RESPONSE FOR IV TUBING, PRIMARY MACRO 2 INJ. SITE SET (PER SITE REPORTER): THERE HAS BEEN CONTINUED CONTACT BETWEEN THE MATERIALS MANAGEMENT DEPT AND WITH THE PRODUCT SURVEILLANCE QUALITY ASSOCIATE FROM BAXTER HEALTHCARE CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866219 CONTINU-FLO SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION R16J06066 OR R16J04046

    Patients

    Seq Age Sex Outcome Treatment
    1