BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2822660 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04289
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER CANADIAN TECHNICAL SERVICES TO REPORT A MINI-VOLUME EXTENSION SET, 74 WITH LUER LOCKS, THAT WAS CAUSING PUMPS TO ALARM. THE CUSTOMER STATED THAT IS 'APPEARS [TO HAVE HAD] A MANUFACTURE CHANGE TO THE MALE END. IT IS ONLY ABOUT 1/2 THE DIAMETER OF THE OLDER TUBING AND NOW THE CUSTOMER'S IV PUMPS ARE FREQUENTLY RINGING OFF AND THE LINE IS DIFFICULT TO PRIME.' ON (B)(6) 2012 THE CUSTOMER LATER PROVIDED ADDITIONAL INFORMATION, STATING THAT THE SAMPLE WAS DEFECTIVE, AS THE SET ONLY HAD A MICRO OPENING. THEY WENT ON TO SAY THAT 'LIPIDS AND BLOOD DO NOT PASS THROUGH", "CAUSING CONSTANT OCCLUSION ALARMS ON THE PUMPS IN NICU." THE CUSTOMER FINISHED BY SAYING THAT "THE NARROWER DIAMETER OF THE MALE CONNECTOR MAKES THE SETS UNACCEPTABLE FOR USE,' AS THEY COULD NOT PRIME THE LINE. IT IS UNKNOWN WHAT PROCESS STEP THE REPORTED MALFUNCTION OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; THERE WAS NO 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 - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1