BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4250122 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40227
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED FROM JUNE 26, 2014 THROUGH JUNE 27, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION (VIA THE NAKED EYE) REVEALED THE PRESENCE OF TWO BROWN, IRREGULARLY SHAPED PARTICLES, APPROXIMATELY 0.15MM IN LENGTH. MICROSCOPIC INSPECTION REVEALED THAT THE PARTICLES WERE NOT IN THE FLUID PATH BECAUSE THEY WERE EMBEDDED IN A COMPONENT MATERIAL. THE REPORTED CONDITION WAS VERIFIED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THIS ISSUE IS CURRENTLY BEING ADDRESSED THROUGH A CAPA. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HEALTHCARE LTD COMPOUNDING UNIT. THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FIBER IN THE BALLOON OF A LARGE VOLUME INFUSOR. THE DEVICE WAS FILLED WITH FLUOROURACIL. THIS WAS FOUND BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737676 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F054

    Patients

    Seq Age Sex Outcome Treatment
    1