BEUDAMED
    FDA Adverse Event Summary report: N

    ALARIS MEDLEY MEDICATION SAFETY SYSTEM

    MDR report key: 548840 · Received July 13, 2004

    Report

    Report Number
    MW1032713
    Date Received
    July 13, 2004
    Date of Event
    July 8, 2004
    Report Date
    July 13, 2004
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/12/04: NOTIFICATION STATED THE NURSE FOUND AIR IN THE DISPOSABLE TUBING PAST THE AIR IN LINE SENSOR AND THE DEVICE HAD NOT ALARMED. A COPY OF THE VOLUNTARY MEDWATCH WAS NOT RECEIVED. THE DEVICE WAS TESTED BY THE FACILITIES BIO MEDICAL ENGINEERING DEPT AND WAS FOUND TO BE OPERATING WITHIN SPECIFICATIONS AND ALARMING FOR AIR IN LINE APPROPRIATELY. THE EVENT LOG INDICATED THERE HAD BEEN TWO (2) AIR IN LINE ALARMS WHICH WERE NOTED BY THE USER. THE DEVICE AND THE DISPOSABLE WERE RETURNED TO ALARIS MEDICAL SYSTEMS, INC. FOR TESTING OR INVESTIGATION. SUMMARY OF EVAL: THE LVP WAS THOROUGHLY TESTED AND FOUND TO BE DETECTING AIR PROPERLY. AN EXAMINATION OF THE DISPOSABLE SET FOUND THE DRIP CHAMBER BELOW THE BURETTE WAS PARTIAL COLLAPSED INDICATING THAT WHILE IN USE THE VENT MAY NOT HAVE BEEN OPENED. A REVIEW OF THE EVENT LOG FOR THE TIME IN QUESTION FOUND SEVERAL AIR IN LINE ALARMS, HOWEVER, THESE MAY HAVE BEEN DURING BIO MED TESTING. CONCLUSION: THE DEVICE AND PRODUCT WORKS AS INTENDED. THE CONCLUSION WAS DETERMINED TO BE A USER ERROR AND THE CUSTOMER WAS NOTIFIED TO REVIEW THE CORRECT USE AND PROPER BURETTE SET UP. THE EVENTS WERE NOT ATTRIBUTABLE TO THE DEVICE.

    Description of Event or Problem · 1

    NURSE REPORTED THAT THERE WAS AIR IN LINE WITHOUT ALARM. THE AIR WAS CAUGHT BEFORE IT GOT TO THE PT. THE PT WAS IN ICU. NURSE STATED THAT THERE WAS NO AIR IN LINE ALARM. WHEN THE UNIT WAS TESTED IT WAS FOUND TO ALARM WITH AIR IN THE LINE. CHECKING THE LOG THERE WAS TWO AIR IN LINE ALARMS THAT WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS MEDLEY MEDICATION SAFETY SYSTEM INFUSION PUMP FRN ALARIS MEDICAL SYSTEMS 8000BX03EE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *