BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD-LEGACY PCA AMBULATORY INFUSION PUMP

    MDR report key: 866072 · Received June 14, 2007

    Report

    Report Number
    2183502-2007-00184
    Event Type
    Death
    Date Received
    June 14, 2007
    Date of Event
    May 2, 2005
    Report Date
    June 12, 2007
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    MEA
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE ARE THE ONLY DETAILS AVAILABLE AT THIS TIME. BOTH THE NURSE AND THE CO ARE IMPLICATED IN THE LAWSUIT, AND THE MANUFACTURER HAS BEEN TOLD THEY ARE NOT ALLOWED TO CONTACT THEM FOR FURTHER DETAILS.

    Description of Event or Problem · 1

    ON 05/16/2007 THE MANUFACTURER WAS SERVED WITH A LAWSUIT WHICH IMPLICATED THE MANUFACTURER'S DEVICE WAS INVOLVED IN THE DEATH OF A PATIENT. THIS LAWSUIT IS THE MANUFACTURER'S FIRST NOTIFICATION OF THE ALLEGED INCIDENT. THE ONLY DETAILS MADE AVAILABLE ARE AS FOLLOWS: IN MID 2005, PT WAS RELEASED TO HOME HEALTH CARE AFTER HAVING A SURGICAL REPAIR TO A TORN RIGHT SHOULDER ROTATOR CUFF--WITH INSTRUCTIONS TO RECEIVED IV MORPHINE 2 MG/HOUR CONTINUOUS AND 2 MG BOLUS/ FIFTEEN MINUTES (AS NECESSARY). THE NURSE CAME TO THE PT'S HOUSE AND SET UP THE DEVICE. THE NURSE WORKS UNDER CONTRACT. PT DIED AT 4:35 P.M. THAT SAME DAY FROM TOXIC COMPLICATIONS OF MORPHINE. THIS INCIDENT OCCURRED. THESE ARE THE ONLY DETAILS AVAILABLE AT THIS TIME. THE MODEL OR SERIAL NUMBER FOR THE DEVICE ARE NOT AVAILABLE. BOTH THE NURSE AND 1ST AMERICA ARE IMPLICATED IN THE LAWSUIT, AND THE MANUFACTURER HAS BEEN TOLD THEY ARE NOT ALLOWED TO CONTACT THEM FOR FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD-LEGACY PCA AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP MEA SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 6300 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death