BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3854076 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18200
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE UNIT FOR EVALUATION CONTAINING 84ML OF FLUOROURACIL AND DILUENT 0.9% SODIUM CHLORIDE. VISUAL INSPECTION SHOWED NO SIGNS OF PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED CONDITION. FLUID WAS DRAINED, AND A FUNCTIONAL FLOW RATE TEST WAS PERFORMED; THE FLOW RATE WAS FOUND TO BE WITHIN SPECIFICATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS ANTICIPATED. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR ELASTOMERIC DEVICE EXPERIENCED AN UNDERINFUSION OF FLUOROURACIL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330681 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14C021

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL