BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL NON-DEHP CONTINU-FLO SET10 DPM, 110", 3 CL SITES

    MDR report key: 1973412 · Received January 30, 2011

    Report

    Report Number
    6000001-2011-00504
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 4, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY AND FUNCTIONALLY TESTED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE SAMPLE PASSED VISUAL INSPECTION, SLIT VISUALIZATION TESTING, CLEAR AIR PASSAGE TESTING AT 0.25 PSI FOR 30 SECONDS, REFEREE TESTING OF THE CLEARLINK Y-SITES AT 0.25 PSI FOR 30 SECONDS, AND FLUID PATH OCCLUSION TESTING. THEREFORE, AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE THAT THEY ARE HAVING DIFFICULTY ESTABLISHING FLOW AT THE UPPER Y-SITE OF THE CLEARLINK NON-DEHP CONTINU-FLO SOLUTION SET AFTER CONNECTING AN UNKNOWN BAXTER SECONDARY SET. THEY DON'T NORMALLY TAP AND INVERT THE BACKCHECK VALVE. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL NON-DEHP CONTINU-FLO SET10 DPM, 110", 3 CL SITES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BAXTER SECONDARY SET