BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U0605 6464602 PCA II PUMP

    MDR report key: 1040231 · Received May 9, 2008

    Report

    Report Number
    6000001-2008-00316
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 20, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE EVAL OR IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON 4-25-2008 BAXTER WAS NOTIFIED THAT A PT WAS OVERDOSED WITH DILAUDID THREE TIMES WITH THREE DIFFERENT PCA II PUMPS. THE PT WAS STARTED ON THE DILAUDID INFUSION ON A WEEK EARLIER AT A BASAL RATE OF 0.1 MG/HR FOR THIS PUMP. THE AVAILABLE DOSE WAS 0.1 MG EVERY 10 MINS AS NEEDED FOR PAIN. THE SYRINGE WAS NOTED TO BE EMPTY ON THE SAME DAY. THE PT WAS THEN CONNECTED TO A SECOND PUMP ON THE FOLLOWING DAY, WHICH WAS LOADED WITH DILAUDID AND SET AT A BASAL RATE OF 0.1 MG/HR. THE AVAILABLE DOSE WAS 0.1 MG EVERY 10 MINS AS NEEDED FOR PAIN. THE SECOND PUMP WAS ALSO NOTED TO OVER INFUSE WHEN THE SYRINGE WAS EMPTY ON THE SAME DAY. THEN THE THIRD PUMP WAS CONNECTED ON THE NEXT DAY AT THE BASAL RATE OF 0.1 MG/HR. THE AVAILABLE DOSE WAS 0.1 MG EVERY 10 MINS AS NEEDED FOR PAIN. THE SYRINGE WAS EMPTY ON THE SAME DAY. THE PT IS A FEMALE WHO WAS DIAGNOSED FOR SICKLE CELL ANEMIA. THIS PT IS ALLERGIC TO MORPHINE AND SO WAS PRESCRIBED DILAUDID FOR PAIN. THE PT IS KNOWN TO BE MANIPULATIVE AND MAY HAVE TAMPERED WITH ALL THREE OF THE PCA PUMPS WHICH OVERINFUSED FOR THREE DAYS FROM A WEEK PRIOR TO ORIGINAL DATE. NARCAN WAS GIVEN FOR THE INCIDENT WHICH OCCURRED ON THE SECOND DAY. NARCAN WAS NOT GIVEN ON THE FIRST DAY AND THE THIRD DAY. THE PT RECOVERED AND WAS DISCHARGED FROM THE HOSP ON TWO DAYS LATER. THE PUMP IN THIS REPORT WAS INVOLVED IN THE SECOND DAY INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0605 6464602 PCA II PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention