BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2863853 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06821
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS A PRODUCT NOT DISTRIBUTED IN THE U.S. AND DOES NOT HAVE A 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION, PRESSURE TESTING AND FUNCTIONAL TESTING WERE PERFORMED; NO NON-CONFORMITIES WERE OBSERVED. THE CUSTOMER'S REPORTED MALFUNCTION WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A LABEL REVIEW WAS PERFORMED, WHICH FOUND THAT THE LABELING WAS SUFFICIENT IN PROVIDING INFORMATION ON THE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    A FACILITY CONTACTED BAXTER (B)(4) TECHNICAL SERVICES TO REPORT THAT SINCE (B)(6) A FEW PROBLEMS HAVE COME IN, REGARDING THE CLEARLINK SYSTEM CONTINU-FLO SET. IT WAS REPORTED THAT THE SOLUTION "DOES NOT FLOW IN THE SET MAKING IT IMPOSSIBLE TO FILL IT AND USE...." THE CONTACT WAS UNABLE TO CONFIRM IF THE PRIMING INSTRUCTIONS WERE FOLLOWED, BY SQUEEZING THE BAG AND TAPPING AND INVERTING THE CHECK VALVE. IT WAS REPORTED THAT "THE DRIP CHAMBER WAS FULL." THIS MALFUNCTION OCCURRED DURING PRIMING. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; THERE WAS NOT REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12E21118

    Patients

    Seq Age Sex Outcome Treatment
    1