BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLO-LAB

    MDR report key: 2553735 · Received April 24, 2012

    Report

    Report Number
    MW5025179
    Event Type
    Injury
    Date Received
    April 24, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 24, 2012
    Manufacturer
    PARKS MEDICAL ELECTRONICS INC.
    Product Code
    MHX
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TUBING FOR NON-INVASIVE LOWER ARTERIAL VASCULAR STUDY WAS PLUGGED INTO IV LINE PORT INSTEAD OF CUFF TUBING ON RIGHT ARM. INFLATION PROCESS WAS BEGUN. BUT FOR THE SLIDE CLAMP ON THE IB TUBING, A MAJOR AIR EMBOLISM AND PT DEATH WOULD HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-LAB FLO-LAB MHX PARKS MEDICAL ELECTRONICS INC. 2100-SX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability IV SITE TUBING CONNECTOR: ALARIS PRODUCTS| REF #(B)(4)