BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM CONTINU-FLOSOLN SET 0.22 MICRON FILTER

    MDR report key: 1943055 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06470
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 20, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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 8 PSI. 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 SET 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 REGARDING A CLEARLINK CONTINU-FLO SOLUTION SET IN WHICH A NO FLOW WAS DETECTED BELOW THE DRIP CHAMBER AFTER FILLING WITH SOLUTION DURING PRIMING, MOST OFTEN WITH SALINE. PER THE CUSTOMER, THE CLAMPS WERE OPENED ON THE SETS. THIS IS AN ONGOING ISSUE AND HAS OCCURRED IN NUMEROUS DEPARTMENTS. THERE IS NOTHING VISIBLY BLOCKING THE SET. WHEN THE SETS ARE SUCCESSFULLY PRIMED, THEY ARE USED WITH A SIGMA PUMP. WHEN THE SOLUTION BAG IS FORCEFULLY SQUEEZED, SOMETIMES THE SOLUTION WILL FLOW, SOMETIMES IT WILL NOT. 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 CLEARLINK SYSTEM CONTINU-FLOSOLN SET 0.22 MICRON FILTER SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10C03048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION BAG