BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1930934 · Received December 16, 2010

    Report

    Report Number
    6000001-2010-05873
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 8, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED, AND VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. THE REPORTED CONDITION OF NO FLOW WAS NOT CONFIRMED OR DUPLICATED; THEREFORE AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE BATCH REVIEW WAS PERFORMED AND NO DEVIATIONS WERE FOUND. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS EXPERIENCING A NO FLOW. THE REPORTED CONDITION OCCURRED DURING PRIMING. THE NURSE SQUEEZED THE BAG PER LABEL COPY TO INITIATE FLOW. THE NURSE INVERTED AND TAPED THE CHECK VALVE PER LABEL COPY. THE DRIP CHAMBER WAS HALF FULL. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10A03018

    Patients

    Seq Age Sex Outcome Treatment
    1