BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIER PRO

    MDR report key: 7291680 · Received February 23, 2018

    Report

    Report Number
    7291680
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    November 20, 2017
    Report Date
    January 30, 2018
    Manufacturer
    S2S GLOBAL
    Product Code
    KZD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRESSURE BAG WOULD NOT HOLD PRESSURE DESPITE APPROPRIATE USE TO PUMP UP PRESSURE TO 300 MG HG AND SECURE STOPCOCK. NURSE HAD TO REINFUSE PRESSURE INTO THE BAG MULTIPLE TIMES. THIS PRESSURE BAG WAS BEING USED ON THE RADIAL ARTERY LINE. THE PHYSICIAN WAS NOT ABLE TO SAVE THE ARTERIAL LINE AND IT HAD TO BE DISCONTINUED AND RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135843 PREMIER PRO INFUSOR, PRESSURE, FOR I.V. BAGS KZD S2S GLOBAL

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening| R NO OTHER THERAPIES