BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT

    MDR report key: 1932336 · Received December 17, 2010

    Report

    Report Number
    6000001-2010-05897
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 26, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE FOR EVALUATION AND THE FOLLOWING TESTS WERE PERFORMED. A VISUAL INSPECTION WAS PERFORMED TO THE SET AND THE RESULTS WERE SATISFACTORY. A SLIT VISUALIZATION WITH ONE BECTON DICKINSON SYRINGE WAS APPLIED TO THE Y-SITES; THE BASELINE SLIT WAS DETECTED IN THE SAMPLES. A REFEREE TEST WAS APPLIED TO THE ACTIVATED VALVE Y-SITES, AND THE REPORTED CONDITION WAS NOT DETECTED. A FLUID PATH OCCLUSION TEST AND AN UNDER WATER PRESSURE TEST WERE APPLIED TO THE SAMPLE AND A DEFECT WAS CONFIRMED. A BATCH REVIEW WAS PERFORMED AND NO DEVIATIONS WERE FOUND. THE DEFECT WAS CONFIRMED DUE TO CHECK VALVE BEING BLOCKED IN THE CLEAR SIDE. HOWEVER, THE ROOT CAUSE FOR THE BLOCKED CHECK VALVE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) THAT CLEARLINK DUO-VENT CONTINU-FLO SET, WOULD NOT FLOW WHEN PRIMING. IT IS UNKNOWN IF THEY PRIMED PER LABEL COPY. IT IS UNKNOWN IF A PUMP WAS USED. THE CUSTOMER ASSUMES THAT NORMAL SALINE WAS USED TO PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10A07126

    Patients

    Seq Age Sex Outcome Treatment
    1