BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2192163 · Received August 4, 2011

    Report

    Report Number
    6000001-2011-16632
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SENT IN FOR AN EVALUATION. THE UNIT WAS SPIKED INTO A SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER AND RE-PRIMED. THE SECONDARY WAS THEN RE-ATTACHED TO THE FIRST Y SITE. THE SETUP WAS THEN CHECKED FOR BACK FLOW. THE REMAINING TWO Y SITES WERE ALSO CHECKED FOR FLOW USING THE SAME METHOD. THE CENTER SLIT WAS ALSO VISUALLY INSPECTED FOR RE-KNIT IN ALL THREE Y SITES THERE WAS NO BACKFLOW ILLUSTRATED IN THIS SETUP. THE CAUSE FOR THIS REPORTED CONDITION COULD NOT BE IDENTIFIED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE OF A CLEARLINK CONTINU-FLO SOLN SET IN WHICH A SECONDARY INFUSION BACKED UP INTO THE PRIMARY BAG. THE EVENT OCCURRED DURING INFUSION OF A PATIENT WHO WAS BEING TREATED IN THE INTENSIVE CARE UNIT FOR UNKNOWN REASON(S). (B)(4), THE PRIMARY BAG MAKE WAS ALSO UNKNOWN; HOWEVER IN THE PRIMARY BAG WAS "D5" FLUID AND (B)(4). A PUMP WAS NOT REPORTED TO BE USED IN THESE SCENARIOS. THIS CONDITION OCCURRED AT THE BEGINNING OF THE ADMINISTRATION. THERE WAS NO INJURY OR ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R11D01031

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR UNKNOWN SECONDARY SET| MAGNESIUM, UNKNOWN PRIMARY BAG, D5 FLUID