BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2814872 · Received November 1, 2012

    Report

    Report Number
    1416980-2012-03431
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A CLEARLINK NON-DEHP SECONDARY MEDICATION SET IN WHICH A BACKFLOW OCCURRED. ACCORDING TO THE REPORT, THE SECONDARY SET WAS ATTACHED TO THE UPPER MOST Y-SITE ON AN UNKNOWN CAREFUSION PRIMARY SET. THE PRIMARY SET WAS CONNECTED TO AN ALARIS INFUSION PUMP, AND THE SETTINGS WERE VERIFIED. THE NURSE STATED THAT THE PRIMARY BAG WAS LOWERED USING THE BLUE HANGER, WHICH WAS FULLY EXTENDED, INCLUDED WITH THE SECONDARY SET. THE SECONDARY SET WAS ATTACHED TO A MINI-BAG PLUS SOLUTION BAG. THE REPORTER INDICATED THAT THE SOLUTION FROM THE PRIMARY BAG WAS FLOWING INTO THE SECONDARY SOLUTION BAG. THE SECONDARY BAG BECAME SO FULL, IT LOOKED AS THOUGH IT WAS ABOUT TO BURST. THE FACILITY INDICATED THAT THEY SWITCHED TO CAREFUSION SECONDARY TUBING, AND NO FURTHER ISSUES HAVE BEEN OBSERVED. THE ALLEGED DEFECT OCCURRED DURING PATIENT USE. 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 SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 ALARIS INFUSION PUMP| MINI-BAG PLUS| CAREFUSION PRIMARY SET