BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL CONTINU-FLO SOLN SET, 2 LAVS, L/L

    MDR report key: 1914861 · Received December 4, 2010

    Report

    Report Number
    6000001-2010-05536
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE OF PRODUCT CODE (B)(4), LOT UNKNOWN, FOR EVALUATION. THE SAMPLE ARRIVED OUT OF THE POUCH PRIMED. THE SAMPLE WAS SPIKED INTO A 1000 ML SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER AND RE-PRIMED. THE FIRST Y SITE WAS THEN CHECKED FOR FLOW BY ATTACHING A (B)(4) SECONDARY SET SPIKED INTO A 500ML SOLUTION BAG ALSO CONTAINING REVERSE OSMOSIS WATER. IT WAS NOTED THAT THE FIRST Y SITE FLOWED NORMALLY. THE SECOND Y SITE WAS THEN CHECKED FOR FLOW USING THE SAME METHOD WITH NORMAL FLOW NOTED. BOTH CLEARLINK VALVES WERE THEN VISUALLY INSPECTED UNDER A MICROSCOPE AND BOTH VALVES APPEARED NORMAL. BECAUSE BOTH Y SITES FUNCTIONED NORMALLY THE COMPLAINT WILL NOT BE CONFIRMED. 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. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A NO FLOW ON THE UPPER Y-SITE THAT OCCURRED ON (B)(6) 2010 WITH A CLEARLINK CONTINU-FLO SOLUTION SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL CONTINU-FLO SOLN SET, 2 LAVS, L/L SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1