BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 1873002 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04159
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL NARRATIVE: THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION, HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETETION OF THE EVALUATION OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE EVALUATION: ONE UNIT WAS RECEIVED BY BAXTER FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THE DISTAL END LUER LOCK TO BE BROKEN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT THE PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT THE TUBING OF ONE (1) CE INTERMATE LV100 DEVICE WAS DISCOVERED BROKEN OFF AT THE JUNCTION OF THE LUER LOCK AND BLUE WINGED CAP. THE CUSTOMER OBSERVED THIS WHILE FILLING THE DEVICE WITH NORMAL SALINE. THERE HAS BEEN NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 5 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 100, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10A002

    Patients

    Seq Age Sex Outcome Treatment
    1