BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLO-LAB

    MDR report key: 2927187 · Received January 15, 2013

    Report

    Report Number
    3020115-2012-00001
    Event Type
    Other
    Date Received
    January 15, 2013
    Date of Event
    April 17, 2012
    Report Date
    January 14, 2013
    Manufacturer
    PARKS MEDICAL ELECTRONICS, INC. (PMEI)
    Product Code
    MHX
    PMA / PMN Number
    K944495
    Removal / Correction Number
    Z-0443-2013
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD CORRECTION IS ONGOING FOR ALL UNITS. PARKS PROJECT# (B)(4) AUTHORIZES CUFF HOSE CONNECTOR THAT IS NOT COMPATIBLE WITH LUER FITTINGS. THIS WILL COMPLY WITH AAMI / ANSI / ISO 80369-1, SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS. AFTER COMPLIANCE WITH THE STANDARD AAMI/ANSI/ISO 80369-1, LUER FITTINGS WILL CONTINUE TO BE USED FOR INTRAVENOUS APPARATUS ONLY, NONE ON PARKS PRODUCTS.

    Description of Event or Problem · 1

    (B)(4). 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 IV TUBING, A MAJOR AIR EMBOLISM AND PT DEATH WOULD HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22674 FLO-LAB FLO-LAB MHX PARKS MEDICAL ELECTRONICS, INC. (PMEI) 2100-SX NA

    Patients

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