BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3130646 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13426
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE DEVICE WAS RECIEVED FOR EVALUATION. FUNCTIONAL LEAK TESTING IDENTIFIED THAT LEAKAGE WAS OBSERVED UNDER WHERE THE CLEAR FILM WRAP IS LOCATED ON THE BLADDER. THE CAUSE OF THE LEAK WAS A HOLE OF UNKNOWN ORIGIN. THE CAUSE OF THE HOLE COULD NOT BE DETERMINED. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAK WAS OBSERVED IN A CE INFUSOR SV 2 AT THE END OF INFUSION WITH FLUOROURACIL. THE CUSTOMER REPORTED SEEING AN UNSPECIFIED NUMBER OF MILLILITERS OF SOLUTION INSIDE THE HOUSING, BETWEEN THE BLADDER AND RESERVOIR, UPON REMOVAL OF THE DEVICE. A PATIENT WAS INVOLVED, HOWEVER, THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231657 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12J038

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL