BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION INFUSION PUMP

    MDR report key: 6331549 · Received February 10, 2017

    Report

    Report Number
    MW5067898
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    January 26, 2017
    Report Date
    February 10, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OXYTOCIN STARTED @ 2256, THE MEDICATION WAS SCANNED AND 2 RN VERIFICATION DONE INCLUDING RATE AND MEDICATION VERIFICATION ON IV PUMP, AND LINE VERIFICATION BEFORE STARTING PUMP. AFTER START BUTTON HIT TO BEGIN INFUSION IT WAS NOTED BY BOTH RNS THAT THE OXYTOCIN WAS FREE-FLOWING FROM THE BAG AND NOT AT THE SET RATE OF 2MU/MIN. PUMP IMMEDIATELY STOPPED (APPROXIMATELY 5 SECONDS) BUT UNKNOWN AMOUNT OF OXYTOCIN BOLUSED DURING THIS PERIOD. PUMP SETTINGS WERE VERIFIED AGAIN. A NEW PUMP WAS OBTAINED AND THE IV INFUSION RATE AND FLOW WAS RESTARTED. AT 2302, THE OXYTOCIN WAS STOPPED DUE TO A 4 MINUTE TETANIC CONTRACTION (NO UTERINE RELAXATION DURING THIS 4 MINUTE PERIOD) WITH CONCURRENT 3 MINUTE FHT DECELERATION WITH NADIR AT 80 BEATS/MINUTE. FHT'S RECOVERED SPONTANEOUSLY WHEN CONTRACTION WAS OVER AND UTERUS RELAXED. IN ADDITION TO STOPPING OXYTOCIN RESUSCITATION MEASURES INCLUDED POSITION CHANGE AND IV FLUID BOLUS. INITIAL PUMP BRAIN: #FFP 2865 PUMP MODULE: #5225.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107302 CAREFUSION INFUSION PUMP INFUSION PUMP FRN CAREFUSION 5225

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention