BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 5, 12 PACK

    MDR report key: 1760335 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-01739
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).ACCORDING TO THE CUSTOMER, THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF THE DEVICE DELIVERING IN A FASTER THAN EXPECTED TIME CANNOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR LV 5 DEVICE DELIVERED IN A FASTER THAN EXPECTED TIME DURING A PATIENT INFUSION. THE INTENDED INFUSION WAS A SOLUTION OF VANCOMYCIN, AT A CONCENTRATION OF 8.33MG/ML, AND 120 ML OF 0.9% SODIUM CHLORIDE TO BE INFUSED OVER 24 HOURS. HOWEVER, THE ENTIRE AMOUNT INFUSED IN 10 HOURS. 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 LV 5, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10C012

    Patients

    Seq Age Sex Outcome Treatment
    1