BEUDAMED
    FDA Adverse Event Summary report: N

    SYMBIQ

    MDR report key: 1870324 · Received September 22, 2010

    Report

    Report Number
    1870324
    Date Received
    September 22, 2010
    Date of Event
    December 9, 2009
    Report Date
    September 21, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FPA
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE RESPONDING TO A CODE, AN IV WAS ORDERED. THE NURSE PULLED A NEW IV SET FROM A SEALED CRASH CART, OPENED THE PACKAGE, AND TRIED TO INSERT THE IV CASSETTE INTO A HOSPIRA SYMBIQ IV PUMP. AFTER SEVERAL ATTEMPTS TO INSERT THE CASSETTE, ANOTHER NURSE POINTED OUT THAT THE IV SET WAS INTENDED FOR A HOSPIRA PLUM SERIES IV PUMP, OF WHICH THIS PARTICULAR HOSPITAL HAS NONE. THE CORRECT IV SET WAS LOCATED NEARBY IN GENERAL SUPPLIES AND IV THERAPY WAS DELIVERED TO THE PATIENT. ALTHOUGH THERE WAS A DELAY IN ADMINISTERING MEDICATIONS TO THE PATIENT DURING A LIFE-THREATENING EVENT, THE PATIENT WAS REVIVED WITH NO APPARENT INJURY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DURING THE OPENING OF A NEW HOSPITAL ,2 YEARS AGO, HOSPIRA PLUM SERIES PUMPS WERE TRANSITIONED TO THE SYMBIQ PLATFORM. HOSPIRA REPRESENTATIVES WERE ON-SITE TO ENSURE ALL PLUM SUPPLIES WERE REPLACED WITH SYMBIQ. IT WAS FOUND THAT CRASH CARTS WERE OVERLOOKED IN THE INVENTORY PURGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ INFUSION SET FPA HOSPIRA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR