BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2882501 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07864
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE ACTUAL SAMPLE WAS RETURNED TO THE MANUFACTURING PLANT FOR EVALUATION. THE UNIT WAS RECEIVED FULL OF SOLUTION, AND WITHOUT TIP PROTECTORS. FUNCTIONAL TESTING WAS PERFORMED ON THE SAMPLE. THE SPIKE WAS INSERTED IN THE SOLUTION CONTAINER, CLAMP WAS OPENED, AND THE SET WAS PRIMED. A CLEAR PASSAGE AND A PRESSURE TEST WERE PERFORMED AT 8PSI. THE RESULTS WERE SATISFACTORY FOR ALL FUNCTIONAL TESTS. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A CLEARLINK CONTINU-FLO SOLUTION SET IN WHICH A NO FLOW WAS OBSERVED. ACCORDING TO A REPORT, THE NURSE STARTED AN IV AND ATTACHED AN UNKNOWN BAXTER Y-JUNCTION CATHETER EXTENSION SET. THE NURSE INDICATED THAT EXCELLENT BLOOD RETURN WAS OBSERVED WITH THE EXTENSION SET. SHE ALSO INDICATED THAT FLOW WAS ESTABLISHED THROUGH BOTH LUER ACTIVATED DEVICES ON THE EXTENSION SET. THE NURSE PRIMED THE CLEARLINK CONTINU-FLO SOLUTION SET WITH NO ISSUES. THE NURSE THEN CONNECTED THE CLEARLINK CONTINU-FLO SOLUTION SET TO THE EXTENSION SET AND NO FLOW WAS OBSERVED. THE NURSE INDICATED THAT ALL Y-SITES ON THE CLEARLINK CONTINU-FLO SOLUTION SET FLUSHED WITH NO ISSUES. THE CLEARLINK CONTINU-FLO SOLUTION SET WAS SWITCHED OUT AND THERAPY CONTINUED AS NORMAL. THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BAXTER Y-JUNCTION CATHETER EXTENSION SET