BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP PAIN MANAGEMENT PUMP

    MDR report key: 1210029 · Received October 21, 2008

    Report

    Report Number
    6000001-2008-00653
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 2, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    MEA
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT YET BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A PUMP THAT IS CONTINUING TO PUMP WITH THE COVER OPEN AND DID NOT ALARM. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING AN INFUSION. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PAIN MANAGEMENT PUMP 80FRN MEA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1