BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI PC -2TX DUAL-CHANNEL INFUSION PUMP

    MDR report key: 1387670 · Received May 6, 2009

    Report

    Report Number
    2016493-2009-00044
    Event Type
    Injury
    Date Received
    May 6, 2009
    Date of Event
    March 18, 2009
    Report Date
    April 8, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K933144
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. FOLLOW UP REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFO. A COPY OF THE USER FACILITY MEDWATCH IS ATTACHED TO THIS REPORT. GEMINI DEVICES ARE NO LONGER MANUFACTURED, SOLD OR SERVICED BY MFR.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "PATIENT WAS STARTED ON A HEPARIN DRIP AT 8.1 CC/H (810 UNITS/HR) AT 0200. AT 0745 THE 250 CC BAG WAS FOUND EMPTY. THE PUMP WAS PROGRAMMED CORRECTLY AND VERIFIED BY A SECOND STAFF MEMBER BEFORE STARTING THE DRIP. AT A RATE OF 8.1 CC/H, THE BAG SHOULD HAVE LASTED OVER 30 HOURS. THE PUMP WAS TAKEN OUT OF SERVICE AND SENT TO BIOMEDICAL SERVICES TO BE CHECKED. BIOMED TESTED THE PUMP AND CONFIRMED IN 2009 THAT PUMP MALFUNCTIONED. THIS PUMP WAS LEASED FROM A RENTAL COMPANY: HOSPITAL SERVICES. THE SITE WAS CONTACTED AND ADDITIONAL INFORMATION OBTAINED INDICATED THAT THE PT'S PTT ELEVATED, AND THE PT HAD BLOODY STOOLS WITH HGB DECREASED. TWO UNITS OF PRBC WERE GIVEN. AFTER THE PT RECEIVED BLOOD AND HEPARIN WAS STOPPED, THE PT RETURNED TO NORMAL STATE. THE FACILITY REPORTS THAT THEY HAVE HAD THE PUMP FROM RENTAL COMPANY SINCE LATE 2008. CHANNEL A IS BROKEN AT THE BOTTOM; GIVES CONSTANT ALARM WHEN THE SET IS LOADED BECAUSE DOOR IS NOT LINING UP PROPERLY WITH MAGNET NEAR AIL SENSOR. CHANNEL B WHICH WAS INVOLVED IN THE INCIDENT WAS TESTED BY THE BIOMED AT EVENT RATE OF 8.1 ML/HR AND SHOWED FAST/SLOW/FAST/SLOW INFUSION. BIOMED SUSPECTS THE DEVICE MAY HAVE BEEN DROPPED AND SUSTAINED INTERNAL DAMAGE WHICH IS ALLOWING UNREGULATED FLOW. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI PC -2TX DUAL-CHANNEL INFUSION PUMP IV PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 1325D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention