BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4162053 · Received October 10, 2014

    Report

    Report Number
    1416980-2014-35262
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM JUNE 17, 2014 TO JUNE 18, 2014. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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. A VISUAL INSPECTION ON THE UNIT (VIA THE NAKED EYE) NOTED A SOLID WHITE PARTICLE APPROXIMATELY 0.25 AND 0.30 MM IN SIZE, FLOATING IN THE FLUID OF THE RESERVOIR. THE PARTICLE WAS IDENTIFIED TO BE POLYESTER MATERIAL VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) SPECTROPHOTOMETER SCANNING. THE ORIGIN OF THIS MATERIAL IS UNABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER; EVALUATION IS CURRENTLY IN PROCESS BUT HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HALF DAY INFUSOR HAD PARTICULATE MATTER INSIDE OF THE RESERVOIR. THE PARTICULATE WAS IDENTIFIED AFTER THE DEVICE WAS FILLED WITH DESFERRIOXAMINE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643944 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F033

    Patients

    Seq Age Sex Outcome Treatment
    1