BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, 24 PACK,50126

    MDR report key: 2022666 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01959
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "BROKEN JUNCTION NEAR THE LUER LOCK AND BLUE WINGED CAP" WAS CONFIRMED. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. NO OTHER OBSERVATION WAS FOUND. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM; THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER HEALTHCARE THAT ONE (1) CE INTERMATE LV250 DEVICE WAS DISCOVERED WITH BROKEN TUBING NEAR THE LUER LOCK/BLUE WINGED CAP JUNCTION. ACCORDING TO THE CUSTOMER, THIS WAS OBSERVED OUT OF THE PACKAGING/BEFORE USE. THIS DEVICE DOES HAVE THE BROKEN END PIECE TO EVALUATE. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 250, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10M079

    Patients

    Seq Age Sex Outcome Treatment
    1