BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3871749 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18868
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS MANUFACTURED MARCH 12, 2014 ¿ MARCH 13, 2014 EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION NOTED WHITE PARTICLES BETWEEN 0.30 AND 2.00 MM IN SIZE INSIDE THE FLUID PATH. THE PARTICLES WERE IDENTIFIED TO BE ACRYLIC MATERIAL VIA FOURIER TRANSFORM INFRARED SPECTROPHOTOMETER SCANNING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A CAPA WAS OPENED TO INVESTIGATE THE CAUSE OF THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN THE BLADDER OF A SMALL VOLUME FOLFUSOR. THIS WAS DISCOVERED DURING FILLING OF THE DEVICE WITH FLUOROURACIL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350450 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14C037

    Patients

    Seq Age Sex Outcome Treatment
    1