BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 2072313 · Received April 28, 2011

    Report

    Report Number
    6000001-2011-03280
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE RESULTS OF EVALUATION COULD NOT BE COMPLETED AND THE REPORTED CONDITION OF A NO FLOW COULD NOT BE CONFIRMED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF ONE (1) CE INFUSOR LV10 DEVICE WHICH WAS FILLED WITH TIMENTIN 9.3G. THE DEVICE REPORTEDLY FAILED TO RUN. THIS OCCURRED WHILE A PATIENT WAS CONNECTED. HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS IS TOTAL REPORT NUMBER 3 OF 5 FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV10, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10N070

    Patients

    Seq Age Sex Outcome Treatment
    1 TIMENTIN