BEUDAMED
    FDA Adverse Event Summary report: N

    ABBOTT

    MDR report key: 505975 · Received January 12, 2004

    Report

    Report Number
    505975
    Date Received
    January 12, 2004
    Date of Event
    December 2, 2003
    Report Date
    December 9, 2003
    Manufacturer
    ABBOTT LABORATORIES, HOSPITAL PRODUCTS DIV
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN INFUSION OF PITOCIN INITIATED MEDICATION IV PUMP WAS SET UP WITH DOOR CLOSED AND PROPERLY SET UP, PITOCIN BEGAN FREE FLOWING. PT STARTED HAVING HYPERTONIC CONTRACTIONS WITH RESULTING FETAL HEARTRATE DECELERATIONS. (PT RECEIVED APPROX 50CC BOLUS OF PITOCIN), IV FLUIDS WERE INCREASED. INFANT WAS BORN BY SPONTANEOUS VAGINAL DELIVERY APPROX 1 1/2 HOURS AFTER BOLUS, WITH APGARS OF 8 & 9 WITH ARTERIAL CORD BLOOD GASES HCO3-27 CALC SAT 9.3, BASE EXCESS -2.7, CO2 CONTENT 29, PH 7.21, PCO 2.65 AND PO2 12. PT AND INFANT DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT INFUSION PUMP FRN ABBOTT LABORATORIES, HOSPITAL PRODUCTS DIV XLM *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR ABBOTT IV TUBING.