BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM CONTINU-FLOSOLUTION SET 10DPM LARGE BORE

    MDR report key: 1943053 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06469
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FMG
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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. 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. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED CONDITION WAS NOT OBSERVED. 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. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER OF A NO FLOW WITH A CLEARLINK CONTINU-FLO SOLUTION SET. THE 0.9% SALINE BAG WAS SPIKED AND THE FLUID THAT MADE IT TO THE DRIP CHAMBER BUT STOPPED THERE. THERE WAS NO PUMP USED, IT WAS A GRAVITY INFUSION. THE SOLUTION BAG WAS NOT SQUEEZED BUT THE CHAMBER WAS SQUEEZED. THE CUSTOMER DID NOT KNOW WHAT A CHECK VALVE IS AND THE DRIP CHAMBER WAS HALF FULL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM CONTINU-FLOSOLUTION SET 10DPM LARGE BORE STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE R10D06056

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 0.9% NORMAL SALINE