BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV10 SYSTEM

    MDR report key: 1170843 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-01284
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    December 6, 2006
    Report Date
    December 13, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 11 2007. A SAMPLE EVALUATION WAS NOT CONDUCTED AS THE DEVICE INVOLVED IN THIS INCIDENT WAS DISCARDED BY THE REPORTING FACILITY. ALTHOUGH REQUESTED, A COMPANION SAMPLE IS REPORTEDLY UNAVAILABLE. A BATCH REVIEW HAS BEEN CONDUCTED ON LOT NUMBER 06J036 WHICH REVEALED THAT THE LOT PASSED ALL RELEASE CRITERIA. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED CONCERNING AN ELASTOMERIC DEVICE INVOLVED IN AN INCIDENT IN WHICH THE DEVICE INFUSED 249 ML OF CEPHAZOLIN 6000MG DILUTED IN 0.9% NACL IN 21 HOURS INSTEAD OF THE EXPECTED FLOW DURATION OF 24 HOURS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY TO PREVENT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR LV10 SYSTEM ELASTOMERIC INFUSION SYSTEM MEB BAXTER HEALTHCARE CORPORATION NA 06J036

    Patients

    Seq Age Sex Outcome Treatment
    1