BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLEY, PC

    MDR report key: 1002152 · Received January 24, 2008

    Report

    Report Number
    1002152
    Event Type
    Malfunction
    Date Received
    January 24, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 24, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ORDERED A MEDICATION BOLUS FOLLOWED BY A DRIP (GTT) AT 18.4CC/HR. A BOLUS WAS GIVEN AND A GTT WAS STARTED IMMEDIATELY AFTERWARD AT 1145AM. THE PUMP MODULE KEPT BEEPING "AIR IN LINE." THE TUBING WAS TAKEN OUT OF MODULE SEVERAL TIMES IN AN ATTEMPT TO GET AIR OUT; HOWEVER, THERE WERE ONLY VERY SMALL AIR BUBBLES THAT WOULD NOT NORMALLY CAUSE THE PUMP TO ALARM. UPON ATTEMPTING TO REMOVE THE AIR BUBBLES, THE CLAMP (TUBING) WAS OPENED AND THE MEDICATION RAN WIDE OPEN INTO PATIENT. THIS CAUSED THE PATIENT TO RECEIVE APPROXIMATELY 4 HOURS WORTH OF THE MEDICATION IN 1 HOUR. ONCE I REALIZED HOW LOW THE VOLUME IN THE BOTTLE WAS AND WHAT HAD HAPPENED I IMMEDIATELY SHUT OFF THE GTT. NOTIFIED PHARMACY AND THE CHARGE NURSE. BIOMED WAS NOTIFIED OF THE ISSUES I WAS HAVING WITH THE MODULE AND PICKED UP THE PUMP FOR FURTHER EVALUATION. THE PHYSICIAN WAS NOTIFIED AND ORDERS WERE RECEIVED TO STOP THE MEDICATION GTT AND RESTART IN 4 HOURS. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLEY, PC PUMP, IV, MODULE FRN ALARIS MEDICAL SYSTEMS, INC. 8100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR