BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1943051 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06468
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE SAMPLE 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 SAMPLE. THE SAMPLE PASSED FLUID PATH OCCLUSION TESTING, REFEREE TESTING, AND UNDER WATER PRESSURE TESTING AT 8PSI. AN IN-HOUSE SECONDARY MEDICATION SET 2C7461 WAS CONNECTED TO THE PRIMARY SET. 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 DETECTED IN THE SAMPLES. NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER THAT A NO FLOW OCCURRED AT THE UPPER Y-SITE ON (B)(6) 2010 WITH THE CLEARLINK CONTINU-FLO SOLUTION SET. AN UNKNOWN SECONDARY SET, THAT WAS ALREADY PRIMED, WAS ATTACHED TO THE Y-SITE AND WOULD NOT FLOW. THE SECONDARY WAS REMOVED AND A PREFILLED SALINE SYRINGE WAS USED TO TRY AND FLUSH THE Y-SITE, BUT THE SALINE WOULD NOT FLOW EITHER. THE CONDITION OCCURRED DURING PRIMING. THE INFUSION WAS NOT STARTED. A BAXTER PUMP WAS INITIALLY USED, BUT ONCE THE NO FLOW OCCURRED THE SET WAS REMOVED FROM THE PUMP AND A GRAVITY INFUSION WAS ATTEMPTED. NUMEROUS CLINICIANS WERE WITNESS TO THE SITUATION AND ALL CONFIRMED THE TECHNIQUE WAS CORRECT PER THE LABEL COPY. 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 R10E11020

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION BAG, BAXTER PUMP