BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 2, 12 PACK

    MDR report key: 1790217 · Received August 10, 2010

    Report

    Report Number
    6000001-2010-02446
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED AND RECEIVED FOR EVALUATION. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOMES AVAILABLE. A BATCH REVIEW HAS BEEN PERFORMED. ALL RELEASE CRITERIA WERE MET FOR THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR THAT HAD AN OVERINFUSION. THE DEVICE WAS FILLED WITH 300 MILLIGRAMS OF MORPHINE SULFATE IN 240 MILLILITERS OF 0.9% SODIUM CHLORIDE AND WAS CONNECTED TO A PATIENT. THE PUMP WAS ALREADY EMPTY AFTER FOUR DAYS INSTEAD OF FIVE DAYS. THE INFUSION TIME WAS 105 HOURS. NO PORT WAS USED BUT THE INFUSION WAS APPLIED SUBCUTANEOUS. NO OTHER INFUSION HAS BEEN APPLIED THROUGH THE SAME ACCESS. THERE WAS NO ADVERSE EVENT, PATIENT INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10D066

    Patients

    Seq Age Sex Outcome Treatment
    1