BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGON PRESSURE MONITORING LINE

    MDR report key: 96707 · Received June 9, 1997

    Report

    Report Number
    MW1011434
    Event Type
    Injury
    Date Received
    June 9, 1997
    Date of Event
    May 28, 1997
    Report Date
    May 29, 1997
    Manufacturer
    MAXXIM MEDICAL, ARGON DIVISION
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ARTERIAL LINE PRESSURE TUBING DISCONNECTED AT A GLUE-POINT NEAR THE STOP-COCK. THE PT. WAS IN DIC, S/P C-SECTION AND EXPLORATORY LAPAROTOMY WITH MULTIPLE UNITS OF BLOOD & BLOOD PRODUCTS. WHEN THIS PRESSURE LINE CAME APART, THIS PT LOST NEARLY A UNIT OF BLOOD BEFORE THE DISCONNECTION WAS FOUND. THE PT WAS LYING QUIETLY IN BED SO NO UNDUE PRESSURE OR TENSION WAS PLACED ON THIS LINE TO CAUSE THE DISCONNECTION. THE TUBING WAS HUNG AT 1300 ON 5/27/97. IT DISCONNECTED AT 0430 ON 5/28/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGON PRESSURE MONITORING LINE ARTERIAL LINE PRESSURE TUBING DRS MAXXIM MEDICAL, ARGON DIVISION 041-507-503A 2000091RW

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R