BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP PAIN MANAGEMENT SYSTEM US VERSION

    MDR report key: 1061044 · Received June 12, 2008

    Report

    Report Number
    6000001-2008-00372
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 13, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K0529723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO BAXTER SERVICE AND EVALUATION WAS CONDUCTED FOR THE FAILURE TO ALARM DOWNSTREAM OCCLUSION BUT WAS UNABLE TO BE CONFIRMED OR DUPLICATED. THE DEVICE WAS TESTED PER PROCEDURE AND RETURNED TO THE CUSTOMER. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MFG FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    ORIGINAL PAPERWORK RECEIVED BY BAXTER FROM THE CUSTOMER STATED THAT THE DEVICE FAILED TO ALARM DOWNSTREAM OCCLUSION AS EXPECTED. NO INFORMATION WAS PROVIDED AS TO DURING WHAT STAGE OF THE PROCESS THIS OCCURRED. THERE WAS NO REPORT OF PT INJURY BEING ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PAIN MANAGEMENT SYSTEM US VERSION 80FRN FRN BAXTER HEALTHCARE CORPORATION PTE. LTD. NA

    Patients

    Seq Age Sex Outcome Treatment
    1