BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 5, 12 PACK

    MDR report key: 1942670 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06414
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE, HOWEVER IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT TWO INFUSOR LV 5 DEVICES WERE LEAKING DURING PATIENT USE. THIS IS REPORT NUMBER 1 OF 2. THE DEVICES WERE ADMINISTERING OXYCODONE AND A 20 MILLILITER BOLUS OF 0.375% ROPI TO TWO POST OP PATIENTS WHEN THE LEAKS WERE OBSERVED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 0.375% ROPI| OXYCODONE