BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3790835 · Received May 5, 2014

    Report

    Report Number
    1416980-2014-14500
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). EVALUATION INFORMATION: THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS CURRENTLY AWAITING EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED DECEMBER 2, 2013 ¿ DECEMBER 3, 2013. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION WITH APPROXIMATELY 20ML OF FLUID IN ITS BLADDER. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL LEAK TESTING WAS PERFORMED BY FILLING THE DEVICE WITH WATER. DURING AND AFTER FILL, NO EVIDENCE OF A LEAK WAS OBSERVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOLFUSOR LEAKED AT THE FILLING PORT. THIS MALFUNCTION OCCURRED DURING THE FILLING OF THE DEVICE; THEREFORE, THERE WAS NOT PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267695 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13N013

    Patients

    Seq Age Sex Outcome Treatment
    1