BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 4771655 · Received May 14, 2015

    Report

    Report Number
    2016493-2015-00347
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 14, 2015
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A PITOCIN OVER INFUSION WAS NOT CONFIRMED. THE PCU EVENT LOG SHOWED PUMP MODULE S/N (B)(4) WAS PROGRAMMED TO INFUSE "OXYTOCIN INTRAPARTUM" 30UNIT IN 500ML AT A RATE OF 4ML/HR WITH A VTBI OF 450ML AT 6:22 AM ON (B)(6) 2015. THE DEVICE WAS CHANNELED OFF APPROXIMATELY 10 MINUTES LATER. THE VOLUME RECORDED AS BEING INFUSED DURING THIS TIMEFRAME WAS 0.655ML. AT 6:34 AM, THE USER CHANGED THE RATE OF THE PRIMARY INFUSION OF LACTATED RINGERS RUNNING AT 125ML/HR ON PUMP MODULE S/N (B)(4) TO 999ML/HR AND STARTED THE INFUSION WHICH RAN UNTIL 7:17 AM, WHEN IT WAS CHANNELED OFF. THE PRIMARY VOLUME RECORDED AS BEING INFUSED DURING THIS TIMEFRAME WAS 720.068ML. VISUAL INSPECTION AND INTERNAL INSPECTION SHOWED NO ISSUES. FUNCTIONAL AND RATE ACCURACY TESTING WERE WITHIN SPECIFICATION. THE ROOT CAUSE OF A PITOCIN OVER INFUSION WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PITOCIN 30UNITS IN 500ML NS WAS STARTED AT 4UNITS/HOUR, AND 8 MINUTES INTO THE INFUSION THE BABY¿S FETAL HEART TONES DECELERATED AND THE USER NOTED THE IV BAG WAS EMPTY. THE PITOCIN WAS STOPPED AND LACTATED RINGERS WAS HUNG AT 150ML/HOUR. THE PATIENT (MOTHER) ALSO RECEIVED TERBUTALINE 0.25MG SUBCUTANEOUSLY, A FOLEY CATHETER WAS PLACED, AND VITAL SIGNS WERE CHECKED MORE FREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315419 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention (2) 8100, | PRI TUBING,8015, | PRI TUBING,8015, THERAPY DATE (B)(6) 2015