BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MANAGEMENT PUMP

    MDR report key: 1133064 · Received August 22, 2008

    Report

    Report Number
    2921482-2008-00259
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED INCOMPLETE INSTRUCTIONS FOR REVIEWING THE PROGRAMMING OF THE GEMSTAR PUMP. IT WAS REPORTED THAT AFTER STARTING A NEW CONTAINER, THE CUSTOMER CONTACT INDICATED THAT THE INSTRUCTIONS DO NOT INCLUDE ALL OF THE STEPS REQUIRED TO REVIEW THE PUMP PROGRAMMING. THE CUSTOMER CONTACT INDICATED THAT TO REVIEW THE PUMP REPROGRAMMING, THE INSTRUCTIONS DIRECT THE USER TO PRESS THE DOWN ARROW. THE CUSTOMER CONTACT STATED THAT AFTER THE DOWN ARROW IS PRESSED, THE DEVICE CHIRPS AND THE PUMP PROGRAMMING IS NOT DISPLAYED FOR THE USER TO REVIEW. THE CUSTOMER CONTACT STATED THE THERAPY WAS RESUMED AFTER THE NEW CONTAINER WAS STARTED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    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