BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLUTION SET 112"

    MDR report key: 2222994 · Received August 19, 2011

    Report

    Report Number
    MW5021832
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAINTENANCE IV RUNNING WITH A CLEARLINK IV TUBING, WITH 3 INJECTION PORTS AND A BACK CHECK VALVE. A SECONDARY INFUSION (MAG SULFATE) WAS SET UP. WHEN CONNECTED TO THE UPPER Y-SITE, THE SECONDARY BAG BEGAN TO EMPTY RAPIDLY. STAFF FIRST THOUGHT IT WAS THE SECONDARY SET, IT WAS CHANGED, BUT DID NOT RESOLVE THE PROBLEM. IT WAS DISCOVERED THAT THE SECONDARY WAS RUNNING BACK UP INTO THE PRIMARY. IT IS FELT THE PROBLEM IS WITH THE BACK CHECK VALVE. THIS SAME INCIDENT HAPPENED A SECOND TIME WITH SAME LOT NUMBER ON (B)(6) 2011. THE PUMP BEING USED WAS TESTED AND FUNCTIONING WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLUTION SET 112" PRIMARY PUMP TUBING FPA BAXTER HEALTHCARE R11D01031

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR SPECTRUM IV PUMP