BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFUSOR LV5 SYSTEM

    MDR report key: 513559 · Received January 16, 2004

    Report

    Report Number
    6000001-2004-00056
    Event Type
    Other
    Date Received
    January 16, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 22, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED SHOWED SIGNS OF SOLUTION LEAKAGE DURING PT USE. REPORTER STATED DEVICE CONTAINED 5 FLUOROURACIL SOLUTION. REPORTER STATED THAT WHITE PRECIPITATE WAS FOUND AROUND THE DEVICE'S INLET PORT, WHICH WAS A SIGN OF DRUG LEAKAGE. REPORTER FURTHER INDICATED THAT PT WAS EXAMINED FOR COMPLICATIONS OR CHEMO EXPOSURE BUT NONE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR LV5 SYSTEM ELASTOMERIC INFUSION SYSTEM MEB BAXTER HEALTHCARE CORP. NA 03H069

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN