BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2963743 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03930
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    October 19, 2012
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE THE PROBLEM COULD NOT BE CONFIRMED AND THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A USER FACILITY MEDWATCH WAS SENT TO BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A CLEARLINK CONTINU-FLO SOLUTION SET IN WHICH A LEAK WAS OBSERVED. ACCORDING TO THE REPORT, AS SOON AS THE NURSE INSERTED A SPIKE INTO AN UNKNOWN SOLUTION BAG, THE TUBING DIRECTLY BELOW THE DRIP CHAMBER SEPARATED. THE SOLUTION BEGAN RAPIDLY DRIPPING ONTO THE FLOOR. THE NURSE STOPPED THE INFUSION BY OCCLUDING THE HOLE AT THE BOTTOM OF THE DRIP CHAMBER WITH A GLOVED HAND. THE SOLUTION BAG AND TUBING WERE SWITCHED OUT TO PROCEED WITH THE INFUSION. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68028 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR