BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2854634 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06284
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A CLEARLINK CONTINU-FLO SOLN. SET, 3 LUER ACTIVATED VALVES IN WHICH THERE WAS AN OCCLUSION IN THE LINE WHEN THE NURSE ATTEMPTED TO CONNECT AN EXTENSION SET TO THE CLEARLINK AT THE LOWEST Y-SITE. THE EXTENSION SET WAS CONNECTED TO AN UNKNOWN SYRINGE PUMP, AND WAS INFUSING INSULIN. THE PROCESS STEP WAS DURING INFUSION. A NEONATAL PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTS THAT EVERYTHING WAS IN WORKING ORDER, IV SITE WAS PATENT, PUMP WAS OPERATING APPROPRIATELY, AND THE TUBING WAS ATTACHED AND TIGHTENED, BUT IT WAS NOT UNTIL A ONE LINK VALVE WAS ATTACHED BETWEEN THE CLEARLINK VALVE AND THE EXTENSION SET THAT THE OCCLUSION WAS RELIEVED. 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 INSULIN, UNKNOWN SYRINGE PUMP| BAXTER 60" MICRO VOLUME EXTENSION SET