BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 2072296 · Received April 28, 2011

    Report

    Report Number
    6000001-2011-03278
    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
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO FLOW CONDITION NOT CONFIRMED. NO EVIDENCE OF BLOCKAGE OR ABNORMALITY WAS VISUALLY DETECTED FROM THE SAMPLE. DEVICE'S LUER CAP WAS REMOVED AND FLOW WAS READILY OBSERVED AT THE LUER. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE.

    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. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS IS TOTAL REPORT NUMBER 5 OF 5.

    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