BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPUMP PAIN MANAGEMENT SYSTEMUS VERSION

    MDR report key: 1030072 · Received April 15, 2008

    Report

    Report Number
    6000001-2008-00232
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 31, 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
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEERING DEPARTMENT ATTEMPTED TO TEST THE DEVICE AND THEIR CONCLUSION WAS THAT THERE WAS NO PROBLEM WITH THE DEVICE. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY BIOMEDICAL TECHNICIAN REPORTED A POSSIBLE OVERINFUSION OF DILAUDID ON AN UPGRADED PUMP DURING PT USE. THE PT WAS REPORTED TO HAVE BEEN RECEIVING AN INFUSION OF DILAUDID OVER A PERIOD OF 24 HOURS WITH A MAXIMUM HOURLY INFUSION OF 22CC. AT THE CONCLUSION OF THE 24 HOUR PERIOD, THE BAG OF DILAUDID WAS FOUND EMPTY WHEN THE FACILITY BELIEVED THERE SHOULD HAVE BEEN 100-150CC LEFT IN THE BAG. THERE WERE 14 ATTEMPTS MADE BY THE PT TO ADMINISTER A BOLUS, WITH ONLY TWO DELIVERIES NOTED. MEDICAL INTERVENTION WAS REQUIRED. NARCAN WAS ADMINISTERED ONE TIME WITH GOOD RESULTS. THE FACILITY DECLINES TO PROVIDE ADD'L CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PAIN MANAGEMENT SYSTEMUS VERSION 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention