BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 1873175 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04171
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "LEAK" WAS CONFIRMED DUE TO MATERIAL BUILD-UP ON THE INTERNAL DIAMETER OF THE WINGED LUER CAP CAUSING A ROUGHNESS AND THE LEAK TO OCCUR. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE BAXTER (B)(4) MANUFACTURING FACILITY HAS INITIATED AN IMMEDIATE ACTION OF TESTING A REPRESENTATIVE SAMPLE OF ALL FINISHED GOOD PRODUCTS TO DETECT ANY LEAKS AT THE DISTAL END LUER. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL NARRATIVE: PER THE CUSTOMER, THE SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE SAMPLE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INTERMATE LV100 DEVICE WAS OBSERVED LEAKING. IT IS UNKNOWN WHEN THIS WAS OBSERVED. THE DEVICE WAS FILLED WITH 240ML OF 0.9% SODIUM CHLORIDE. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 10G036

    Patients

    Seq Age Sex Outcome Treatment
    1