BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 1920367 · Received December 10, 2010

    Report

    Report Number
    6000001-2010-05723
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "LEAKING" WAS CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THE LEAK WAS CAUSED BY A BROKEN TUBING AT THE JUNCTION OF THE LUER BODY. NO OTHER CAUSE OF LEAK WAS FOUND ON THE SAMPLE. THE ROOT CAUSE ASSOCIATED WITH THIS EVENT IS DUE TO EXCESSIVE FORCE APPLIED DURING FILLING AT THE CUSTOMER SITE. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    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

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INFUSOR LV10 DEVICE WAS OBSERVED LEAKING BEFORE USE. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH FLUCLOXACILLIN (8000MG) AND THE "CONNECTIVE PORT CAME OUT". THERE IS NO PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY OR 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 10H087

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUCLOXACILLIN