BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 5, 12 PACK

    MDR report key: 1212673 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-88942
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 26, 2007
    Report Date
    June 28, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K905778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. A SAMPLE EVALUATION WAS NOT CONDUCTED AS THE DEVICE INVOLVED IN THIS INCIDENT WAS DISCARDED BY THE REPORTED FACILITY. A BATCH REVIEW WAS NOT CONDUCTED, AS THE CUSTOMER CANNOT PROVIDE THE LOT NUMBER OF THE DEVICE INVOLVED. ALTHOUGH REQUESTED, THE REPORTING FACILITY WAS NOT ABLE TO PROVIDE ADDITIONAL INFORMATION. THE MANUFACTURING FAILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILIAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    BAXTER-CANADA RECEIVED A CUSTOMER REPORT CONCERNING A DEVICE OBSERVED TO HAVE INFUSED ITS CONTENTS IN 24 HOURS INSTEAD OF THE EXPECTED 48 HOURS. NO PATIENT INJURY OR MEDICAL INTERVENTION IS ASSOCIATED WITH THIS INCIDENT. THE SAMPLE HAS BEEN NOTED AS NOT BEING AVAILABLE FOR EVALUATION. THE LOT NUMBER OF THE DEVICE IS UNKNOWN. ALTHOUGH REQUESTED, THE REPORTER IS UNABLE TO PROVIDE ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 5, 12 PACK 80MEB MEB BAXTER HEALTHCARE CORPORATION NA01

    Patients

    Seq Age Sex Outcome Treatment
    1