BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 1841423 · Received September 22, 2010

    Report

    Report Number
    6000001-2010-03448
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF AN INFUSOR LV 10 DEVICE WITH ITS TUBING AND LUER SEPARATED WAS CONFIRMED DURING PRODUCT EVALUATION AS THE TUBING BEING BROKEN AT ITS JUNCTION WITH THE LUER. THIS CONDITION WAS LIKELY CAUSED BY THE TUBING COMING INTO CONTACT WITH A SHARP OBJECT. THIS DEVICE IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN ISRAELI DISTRIBUTOR REPORTED TO BAXTER (B)(4) THAT AN INFUSOR LV 10 DEVICE WAS FOUND TO HAVE ITS TUBING AND LUER SEPARATED. THEREFORE, THE STERILE FLUID PATHWAY WAS BREACHED. THIS CONDITION WAS DISCOVERED BY THE PATIENT BEFORE USE. THE DEVICE WAS FILLED WITH A 240 ML SOLUTION OF CEFAZOLIN IN NORMAL SALINE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV10, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09J026

    Patients

    Seq Age Sex Outcome Treatment
    1