BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEMSTAR PAIN MANAGEMENT PUMP

    MDR report key: 1250346 · Received December 3, 2008

    Report

    Report Number
    2921482-2008-00409
    Event Type
    Death
    Date Received
    December 3, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 6, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE HISTORY WAS PRINTED AT THE USER FACILITY. A REVIEW OF THE PUMP HISTORY SHOWS THAT IN 2008 AT 2018, THE PUMP WAS PROGRAMMED TO DELIVER IN THE CONTINUOUS + BOLUS IN MG MODE, CONCENTRATION 1MG/ML, RATE 0.4MG/HOUR, BOLUS DOSE 2MG, BOLUS LOCKOUT 10 MINUTES, BOLUSES PER HOUR 6, CONTAINER 30.59MG AND AIR SENSITIVITY ON AND THE INFUSION WAS STARTED. BETWEEN 2028 AND 2326, THERE WERE 8 PATIENT INITIATED BOLUS DEMANDS AND 7 BOLUS DELIVERIES. ON THE NEXT DAY AT 0000, A NEW DAY STAMP OCCURS. AT 0547, THE INFUSION IS STOPPED. AT 0553 AND 0559, START ALARM OCCURS. AT 0618, THE PUMP IS POWERED OFF. REVIEW OF THE PUMP HISTORY INDICATES THAT THE PUMP DELIVERED AS PROGRAMMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A PATIENT EXPIRED WHILE THE PUMP WAS IN USE. AT AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER DILAUDID 1MG/ML IN THE CONTINUOUS + BOLUS MODE, AT A RATE OF 0.4MG/HR, WITH A 2MG BOLUS DOSE, A 10 MINUTE PATIENT LOCKOUT, 6 BOLUSES PER HOUR, AND A CONTAINER SIZE OF 30.59MG. IN 2008 AT 0640, THE CUSTOMER CONTACT REPORTED THE PATIENT CODED AND RESUSCITATION WAS INITIATED. AT 0710, THE PATIENT EXPIRED. AFTER A REVIEW OF THE PUMP HISTORY, CUSTOMER CONTACT INDICATED THAT THE PUMP DELIVERED AS PROGRAMMED. THROUGH REQUESTED, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR PAIN MANAGEMENT PUMP 80-FRN MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death DILAUDID