BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0311 IPUMP PAIN MANAGEMENTSYSTEM US VERSION

    MDR report key: 2023646 · Received March 18, 2011

    Report

    Report Number
    6000001-2011-01969
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN I PUMP DEVICE WAS PROGRAMMED TO DELIVER A BOLUS OF 1.5 MILLILITERS MORPHINE, THEN WAS REPROGRAMMED TO BOLUS 2.5 MILLILITERS DURING PATIENT USE. THE CUSTOMER STATED THAT THE REPROGRAMMING OCCURRED WITHOUT ANY INDICATION FROM THE DEVICE THAT THE BOLUS AMOUNT WAS BEING CHANGED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE SOFTWARE VERSION OF THIS DEVICE WAS 2.03. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0311 IPUMP PAIN MANAGEMENTSYSTEM US VERSION PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 MORPHINE