BEUDAMED
    FDA Adverse Event Summary report: N

    CADD-SOLIS

    MDR report key: 2921534 · Received November 28, 2012

    Report

    Report Number
    2921534
    Date Received
    November 28, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WE EXPERIENCED AN EVENT WITH THE VOLUME REMAINING IN A PCA CASSETTE AFTER PUMP WAS DISCONTINUED. NURSE RECORDED 25ML REMAINING ON FLOW SHEET BUT PUMP DISPLAYED 44ML REMAINING, THEREFORE A 19ML DISCREPANCY. THE NURSE CAME UP WITH 25ML'S BY PULLING THE REMAINING DRUG OUT OF CASSETTE USING A 10CC SYRINGE. EVENT LOG FROM PUMP IDENTIFIED 1.9ML PRIMED AND TOTAL OF 54ML DELIVERED TO PATIENT FROM A 100ML BAG. USING PCA EVENT LOG DATA AND DOING MATH MANUALLY, 44.1ML'S SHOULD HAVE BEEN REMAINING IN CASSETTE. THE RESEARCH STATES THAT PUMP WAS WORKING CORRECTLY AND DELIVERY COUNTS WERE ACCURATE. SINCE PCA CASSETTES ARE FILLED IN-HOUSE, THE REPEATER PUMP USED IN THE PHARMACY WAS ALSO EVALUATED. DURING SEVERAL TEST LOADS, IT WAS IDENTIFIED THE FLUID VOLUME FROM REPEATER PUMP TO FILL CASSETTES WAS INCONSISTENT AND WOULD UNDER-FILL AT RANDOM INTERVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD-SOLIS PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. SOLIS 2110 *
    2 REPEATER PUMP REPEATER PUMP MEA SMITHS MEDICAL ASD, INC. 099 *
    3 * PUMP, INFUSION, PCA, CASSETTE MEA SMITHS MEDICAL ASD, INC. UNK DRW10/24/12 19:24

    Patients

    Seq Age Sex Outcome Treatment
    1 *