BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 2072295 · Received April 28, 2011

    Report

    Report Number
    6000001-2011-03277
    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). ONE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. NO FLOW CONDITION NOT CONFIRMED. NO EVIDENCE OF BLOCKAGE OR ABNORMALITY WAS VISUALLY DETECTED FROM THE SAMPLES. A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES. THIS IS REPORT 1 OF 5 FOR THE FACILITY.

    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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A COMPLAINT INVOLVING FIVE TOTAL (5) CE INFUSOR LV10 DEVICES WHICH REPORTEDLY FAILED TO RUN AFTER BEING FILLED WITH 9.3G TIMENTIN. THIS COMPLAINT WILL ADDRESS 1 OF 5 TOTAL REPORTS FOR THIS FACILITY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT ASSOCIATED WITH THIS DEVICE, MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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