BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3140911 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-13975
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 7, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). OCCURRENCE DATE IS UNKNOWN. THE DEVICE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION NOTED THE RUPTURED BLADDER IN A NON-FOOTING POSITION. MICROSCOPIC ANALYSIS REVEALED MARKINGS ON THE INTERIOR SURFACE WHICH INDICATE INTERNAL DAMAGE. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE OF THE RUPTURE IS UNDETERMINED. 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 MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A FOLFUSOR SV4 BURST. THIS OCCURRED AFTER FILLING THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244891 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12J079

    Patients

    Seq Age Sex Outcome Treatment
    1