BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP PAIN MANAGEMENT SYSTEMUS VERSION

    MDR report key: 1212403 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-88960
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 26, 2007
    Report Date
    June 26, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION, SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 24, 2007. THE REPORTED CONDITION OF OVER DELIVERY WAS NOT CONFIRMED DURING EVALUATION. A PRE-ACCURACY TEST WAS PERFORMED AND THE DEVICE PASSED THE TEST. THE DEVICE WAS TESTED PER PROCEDURE AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED THAT THE PUMP WAS IN CONTINUOUS MODE AND SET TO DELIVER 10 ML/H, BUT IT DELIVERED APPROXIMATELY 14 ML/H. THIS WAS NOTED DURING BIO-MED TESTING, THEREFORE, NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PAIN MANAGEMENT SYSTEMUS VERSION 80FRN FRN BAXTER HEALTHCARE CORPORATION, SINGAPORE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1