BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3973844 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25131
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 14B023 WAS MANUFACTURED BETWEEN FEBRUARY 4, 2014 AND FEBRUARY 5, 2014. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. ONE ACTUAL UNIT WAS RECEIVED AT THE PLANT FOR EVALUATION. VISUAL INSPECTION ON THE UNIT (VIA THE NAKED EYE), NOTED A RUPTURED RESERVOIR. THE RUPTURED BLADDER WAS MICROSCOPICALLY EXAMINED. AS A RESULT, MARKING LOCATED ON THE EXTERIOR SURFACE OF THE RESERVOIR WAS OBSERVED NEAR THE RUPTURE LINE. THE CONDITION WAS VERIFIED, THOUGH THE CAUSE COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A FOLFUSOR RUPTURED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450327 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B023

    Patients

    Seq Age Sex Outcome Treatment
    1