BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERLINK CONTINU-FLO SOLUTION SET

    MDR report key: 486585 · Received September 26, 2003

    Report

    Report Number
    6000001-2003-08948
    Event Type
    Other
    Date Received
    September 26, 2003
    Date of Event
    August 26, 2003
    Report Date
    August 26, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CLINICIAN REPORTED NOTING A HOLE IN THE IV TUBING DURING PT USE WHILE ADMINISTERING MAGNESIUM SULFATE (MG SO4) TO STOP LABOR. FURTHER FOLLOW UP WITH CLINICIAN REVEALED THAT THE PT INVOLVED IN THE REPORTED EVENT WAS 28 WEEKS OF GESTATINAL AGE. REPORTEDLY, THE CONCENTRATION OF MG S04 WAS 40 GM PER 1000 ML OF LACTATED RINGERS. CLINICIAN STATED THAT PT INITIALLY RECEIVED A 4G BOLUS AT 200 ML/H OVER 30 MINS, THEN THE DRIP WAS INCREASED TO 2G/H AT 50ML/H, AND THEN TO 3G/H AT 75ML/H, PER CLINICIAN, TUBING WAS FOUND TO BE LEAKING WHEN THE DRIP RATE WAS INCREASED TO 3G/H. CLINICIAN STATED THAT THE MG SO4 BOLUS WAS BEING INCREASED BECAUSE PT'S CONTRACTIONS WOULD NOT STOP. REPORTER STATED THAT AS SOON AS THE TUBING WAS CHANGED AND THE MG SO4 BOLUS WAS RESTARTED, THE CONTRACTIONS STOPPED. REPORTER STATED THAT AFTER PT'S CONTRACTIONS STOPPED, THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL AS INITIALLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO SOLUTION SET INTERLINK CONTINU-FLO SET FPA BAXTER HEALTHCARE CORP. NA R03E12191

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other