BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSABLE

    MDR report key: 2163479 · Received July 6, 2011

    Report

    Report Number
    2163479
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 6, 2011
    Manufacturer
    VITAL SIGNS INC.
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE ANESTHESIA TECHNICIAN HAD A 500CC BAG OF SALINE IN THE PRESSURE INFUSOR BAG AND WAS PUMPING UP TO PRESSURIZE IT. THE NETTING THAT HOLDS THE IV BAG IN PLACE BURST AND RIPPED APART AT THE SEAMS. NOTHING ELSE CONTRIBUTED TO THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSABLE INFUSOR, PRESSURE KZD VITAL SIGNS INC. * 1331

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR