BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS MEDICAL

    MDR report key: 3849575 · Received June 2, 2014

    Report

    Report Number
    3849575
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FMG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS RECEIVING MULTIPLE PRESSORS WHEN SHE BECAME ACUTELY HYPOTENSIVE, REQUIRING BOLUSES OF PRESSORS AND FLUIDS AND INCREASES IN HER DRIP RATES. DURING THE TROUBLESHOOTING PROCESSES, THE TEAM NOTED THAT THE BED SHEETS WERE WET AND IDENTIFIED A CRACK IN THE STOPCOCK, WHICH WAS PREVENTING THE MEDICATION FROM REACHING THE PATIENT. THE SETUP WAS CHANGED OUT AND THE PATIENT STABILIZED QUICKLY AND RETURNED TO HER BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322209 SMITHS MEDICAL SMORE BORE STOPCOCK FMG SMITHS MEDICAL MX2341L

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention