BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1941514 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06357
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER SENT IN AN ACTUAL AND A COMPANION SAMPLE THAT WERE EVALUATED FOR NO FLOW. VISUAL INSPECTION WAS PERFORMED ON THE SAMPLES AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE SAMPLES PASSED SLIT VISUALIZATION TESTING WITH AN IN-HOUSE BECTON DICKINSON 10ML MALE LUER LOCK SYRINGE. THE SYRINGE WAS APPLIED TO THE CLEARLINK Y-SITES AND THE BASELINE SLIT WAS DETECTED IN THE SAMPLES. THE SAMPLES PASSED FLUID PATH OCCLUSION TESTING, REFEREE TESTING, AND UNDER WATER PRESSURE TESTING AT 8PSI. AN IN-HOUSE SECONDARY MEDICATION SET (B)(4) WAS CONNECTED TO THE PRIMARY SETS. THE SECONDARY SET WAS HUNG ASSURING THE HEIGHT OF ITS CONTAINER AND CHAMBER ARE ABOVE THE PRIMARY CONTAINER AND CHAMBER. THE PURPOSE OF THIS TEST IS TO CHECK THE GENERAL FUNCTION OF THE PRODUCT AND THE ADEQUACY OF THE DIRECTIONS FOR USE. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE FOUND. THE SETS WORKED ACCORDING TO THE PROCEDURE AND THE REPORTED CONDITION WAS NOT CONFIRMED IN THE SAMPLES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE OF A CONTINU-FLO SET WITH A NO FLOW DETECTED WHEN THE SET IS INVOLVED IN A PIGGYBACK SETUP. THERE WAS ALSO NO FLOW WHEN THE SET WAS ACCESSED BY A BD SYRINGE. ONE OF THE VALVES WAS USED TO ADMINISTER THE ANTIBIOTICS. NO PATIENT INVOLVEMENT WAS REPORTED. 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 R10F09089

    Patients

    Seq Age Sex Outcome Treatment
    1 BD SYRINGE, UNK SECONDARY SET, ANTIBIOTICS