BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2963223 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03863
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 8, 2012
    Report Date
    February 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K832285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO NOT BE AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RECEIVED FOR EVALUATION AND THEREFORE THE CUSTOMER REPORTED CONDITION COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK VENTED NITROGLYCERIN SET WAS OBSERVED TO HAVE SEPARATED TUBING, DURING AN NITROGLYCERIN (NTG) INFUSION. IT WAS OBSERVED DURING THE INFUSION THAT THE PATIENT'S BEDDING WAS WET AND THE SET WAS FOUND TO BE SEPARATED BETWEEN THE DRIP CHAMBER AND THE TUBING. THERE WAS PATIENT INVOLVEMENT AND IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE A FULL DOSE OF THE MEDICATION. HOWEVER THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66955 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FRN BAXTER HEALTHCARE R12B27062

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR