BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3892846 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20173
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 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). MFR DATE: DECEMBER 10, 2013 ¿DECEMBER 11, 2013. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS EVALUATED. VISUAL INSPECTION OF THE DEVICE REVEALED PARTICLES BETWEEN 0.20 TO 0.40 MM IN SIZE. A SPECTROPHOTOMETER SCAN WAS PERFORMED AND THE PARTICLES WERE IDENTIFIED AS ACRYLIC MATERIAL. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A CAPA WAS INITIATED TO ADDRESS THE ISSUE. 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 A LARGE VOLUME FOLFUSOR HAD PARTICULATE MATTER IN ITS BLADDER. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS IDENTIFIED BEFORE PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369207 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13N010

    Patients

    Seq Age Sex Outcome Treatment
    1