BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4123576 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33515
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED DEVICE WAS RECEIVED FOR EVALUATION AGAINST THE REPORTED CONDITION. VISUAL INSPECTION OF THE DEVICE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL LEAK TESTING WAS PERFORMED AND COULD NOT IDENTIFY A LEAK. THE REPORTED CONDITION COULD NOT VERIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOLUTION WAS DETECTED INSIDE OF THE HOUSING OF A LARGE VOLUME FOLFUSOR, INDICATING LEAKAGE HAD OCCURRED. THIS WAS NOTICED DURING PATIENT INFUSION OF FLUOROURACIL AND SODIUM CHLORIDE, APPROXIMATELY HALFWAY INTO THE EXPECTED INFUSION DURATION. A NEW FOLFUSOR DEVICE WAS THEN FILLED FOR THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602220 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14A058

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL| SODIUM CHLORIDE