BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMS DELTEC, INC.

    MDR report key: 533042 · Received June 15, 2004

    Report

    Report Number
    MW1032368
    Event Type
    Malfunction
    Date Received
    June 15, 2004
    Date of Event
    June 12, 2004
    Report Date
    June 15, 2004
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/10/04: AN EXTENSION CHECK OF ALL RECORDS: THE ORIGINAL REPORTER HAS NOT CONTACTED MFR REGARDING THIS ALLEGED INCIDENT, NOR HAS MFR BEEN FORWARDED A COPY OF THE REPORTER'S MEDWATCH FROM CDRH. WITH NO PRIOR KNOWLEDGE OF THE ALLEGED INCIDENT MFR IS UNABLE TO PROVIDE THE ADD'L INFO YOU REQUEST. ADDITIONALLY, NO USER FACILITY INFO OR DEVICE SERIAL NUMBERS WERE IDENTIFIED SO MFR IS UNABLE TO CONTACT THE REPORTER FOR FURTHER INFO REGARDING THE ALLEGED INCIDENT.

    Description of Event or Problem · 1

    PT WAS CONNECTED TO CADD 5400 PUMP IN 2004 FOR 24 HOUR INFUSION OF CYTARABINE. PT RETURNED THE NEXT DAY TO BE DISCONNECTED FROM INFUSION. CADD PUMP WAS IN START MODE AND RUNNING BUT HAD NOT DELIVERED THE MEDICATION. THE INFUSION BAG STILL HAD APPROXIMATELY 800ML REMAINING. CADD PUMP WAS WITHIN ITS SCHEDULED PREVENTATIVE MAINTENANCE. ONE VERBAL REPORT OF DIFFICULTY IN DISCONNECTING CASSETTE FROM PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMS DELTEC, INC. CADD INFUSION PUMP FRN SMITHS MEDICAL MD, INC. 5400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other