BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3100010 · Received May 8, 2013

    Report

    Report Number
    1416980-2013-11705
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE DEVICE WAS RECEIVED WITH FLUID IN THE RESERVOIR. THE REPORTED CONDITION OF A LEAK WAS CONFIRMED. TO VERIFY THE REPORTED CONDITION, THE FILL-PORT CAP WAS REMOVED. UPON REMOVAL, LEAKAGE WAS OBSERVED AT THE FILL-PORT. VISUAL EXAMINATION OF THE DISASSEMBLED UNIT REVEALED THE CAUSE OF THE LEAK WAS A 0.25-MM PARTICLE OF GLASS TRAPPED BETWEEN THE CHECK BAND AND THE STRESS MEMBER. THE GLASS FRAGMENT WAS INTRODUCED INTO THE FLUID PATHWAY DURING FILL WITHOUT THE USE OF A FILTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE NEAR THE FILL PORT DURING THE FILLING OF AN INFUSOR LV5 WITH AN UNKNOWN DRUG. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201330 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12J072

    Patients

    Seq Age Sex Outcome Treatment
    1