BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK

    MDR report key: 1973109 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00471
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE ACTUAL DEVICE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, A PHOTO OF THE DEVICE HAS BEEN RECEIVED BY BAXTER. THE VISUAL/PHOTOGRAPHIC 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). THIS MEDWATCH WAS ORIGINALLY SUBMITTED ON 04/16/2011. IT IS BEING RESUBMITTED ON 04/18/2011 BECAUSE THE ORIGINAL SUBMISSION FAILED. DEVICE EVALUATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED AND CONFIRMED THE REPORTED CONDITION OF A RESERVOIR RUPTURE. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. 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 THROUGH (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER FRANCE THAT THE RESERVOIR OF ONE (1) CE INTERMATE LV250 DEVICE HAD RUPTURED DURING PATIENT USE TOWARDS THE END OF PATIENT THERAPY. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH NEBCINE (TOBRAMYCINE) AND SODIUM CHLORIDE. THE TOTAL FILL VOLUME WAS 125ML FOR AN 30 MINUTE INTENDED INFUSION. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS IS REPORT 2 OF 2 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10B005

    Patients

    Seq Age Sex Outcome Treatment
    1 NEBCINE (TOBRAMYCINE)| SODIUM CHLORIDE