BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3250897 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19947
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELASTOMERIC BALLOON OF A FOLFUSOR LV5 DEVICE DID NOT FILL WITH SOLUTION AND INSTEAD THE SOLUTION FLOWED INTO THE HOUSING. THIS OCCURRED WHILE FILLING THE DEVICE WITH A SALINE SOLUTION USING A LUER-LOCK SYRINGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352648 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12N016

    Patients

    Seq Age Sex Outcome Treatment
    1