BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 5, 12 PACK

    MDR report key: 2031850 · Received March 28, 2011

    Report

    Report Number
    6000001-2011-02247
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A COMPANION SAMPLE FROM THE SAME LOT AS THIS DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AS WELL AS FUNCTIONAL TESTING. A LEAK TEST WAS PERFORMED ON THE SAMPLE BY FILLING THE BLADDER WITH GREEN WATER THEN MONITORED FOR 48 HOURS. AFTER 48 HOURS, NO SIGNS OF LEAK WERE DETECTED. THEREFORE, THE REPORTED CONDITION OF "LEAKING RESERVOIR" WAS NOT CONFIRMED DURING THE PRODUCT EVALUATION. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM; BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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 (B)(4) THAT AN INFUSOR LV 5 DEVICE WAS LEAKING FROM ITS RESERVOIR DURING A PATIENT INFUSION. THEREFORE, THE STERILE FLUID PATHWAY WAS BREACHED. THE DEVICE HAD BEEN INFUSING 5-FLUOROURACIL FOR 36 HOURS WHEN THE LEAK WAS OBSERVED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 6 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 5, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09N066

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL