BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN SET W/1 CL YLL, 10 DPM, 100"

    MDR report key: 1982935 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00789
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 5, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER RETURNED AN ACTUAL AND COMPANION SAMPLE FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE 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. THEREFORE THE CAUSE OF THIS REPORTED CONDITION IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A CONTINU-FLO SET THAT HAD A NO FLOW. IT IS UNKNOWN WHEN THIS REPORTED CONDITION OCCURRED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLN SET W/1 CL YLL, 10 DPM, 100" SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10E31044

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION