BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1943042 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06473
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 28, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED TWO USED SAMPLES FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED CONDITION WAS NOT CONFIRMED. DURING VISUAL INSPECTION, ALL COMPONENTS WERE PRESENT, IN THE RIGHT POSITION, AND COMPLETE. SLIT VISUALIZATION WITH ONE BECTON DICKINSON 10ML MALE LUER LOCK SYRINGE WAS APPLIED TO THE CLEARLINK Y-SITES AND THE BASELINE SLIT WAS DETECTED IN THE SAMPLES. FLUID PATH OCCLUSION AND UNDERWATER PRESSURE TESTING WAS APPLIED TO THE SAMPLES AND THE REPORTED CONDITION WAS NOT DETECTED. THE REFEREE TEST AT 0.25 PSI FOR 30 SECONDS WAS APPLIED TO THE ACTIVATED VALVE CLEARLINK Y-SITES AND THE REPORTED CONDITION WAS NOT DETECTED. AN IN-HOUSE SECONDARY MEDICATION SET WAS CONNECTED TO THE PRIMARY SETS. THE SECONDARY SETS WERE HUNG ASSURING THE HEIGHTS OF THE CONTAINERS AND CHAMBERS ARE ABOVE THE PRIMARY CONTAINER AND CHAMBER. FUNCTIONAL TEST WAS APPLIED TO THE SAMPLES AND THE REPORTED CONDITION WAS NOT DETECTED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE FOUND. THE SETS WORKED ACCORDING TO THE PROCEDURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER THAT THEY ARE HAVING ISSUES WITH THE UPPER PORT BEING BLOCKED ON A CLEARLINK CONTINU-FLO SOLUTION SET. THE CUSTOMER TRIED TO USE THE PORT 3 TIMES. NO AMOUNT OF SQUEEZING THE PIGGYBACK OR TAPPING ANYTHING WOULD FIX IT. IT IS UNKNOWN WHAT MEDICATIONS WERE BEING USED. THE CLEARLINK SECONDARY MEDICATION SET IS WHAT THEY USE FOR SECONDARIES. THE SECONDARY WAS PRIMED AND WAS CONNECTED USING A FIRM PUSH AND TWIST MOTION. IT IS UNKNOWN IF THE DRIP CHAMBER WAS FULL/FLOODED. AN UNKNOWN BAXTER PUMP WAS USED AND IT WORKED FINE. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. 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 R09K09034

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARLINK SECONDARY MEDICATION SET, BAXTER PUMP