BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3210836 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17713
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 13, 2013
    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) A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED THE PRODUCT MET ALL OF THE ACCEPTANCE CRITERIA FOR RELEASE. THE SAMPLE WAS UNAVAILABLE FOR ANALYSIS; THEREFORE, NO EVALUATION COULD BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES FILLING A FOLFUSOR SV2.5 ML/H. THE BALLOON WAS VERY LOP-SIDED AS IT WAS FILLED AND HAD BURST. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY OR ADVERSE EVENT WAS ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310051 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13A005

    Patients

    Seq Age Sex Outcome Treatment
    1