BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3930166 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22404
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHARMACIST

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURE DATE: NOVEMBER 14, 2013 ¿ NOVEMBER 15, 2013. EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. FUNCTIONAL FLOW RATE TESTING SHOWED A CALCULATED FLOW RATE OF 0.45 ML/HR AND A NORMALIZED FLOW RATE OF 0.46 ML/HR. THESE FLOW RATES ARE NOT WITHIN THE ACCEPTABLE RANGE OF 1.8 ¿ 2.2 ML/HR. DURING MICROSCOPIC INSPECTION MICRO AIR BUBBLES WERE OBSERVED WITHIN THE LUMEN OF THE FLOW RESTRICTOR HOUSING¿S GLASS CAPILLARY. THE REPORTED PROBLEM WAS VERIFIED. THE CAUSE OF THE PROBLEM WAS DETERMINED TO BE MICRO AIR BUBBLES WITHIN THE LUMEN OF THE GLASS CAPILLARY. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR UNDERINFUSED. THIS OCCURRED DURING INFUSION OF FLUOROURACIL. THE DEVICE WAS BEING USED WITH A PORT-A-CATH. THE REPORTER STATED THAT AFTER THE EXPECTED THERAPY TIME OF 48 HOURS, THE DEVICE HAD NOT FULLY EMPTIED. THE NURSE CHECKED THE DEVICE'S FLOW RESTRICTOR AND NO SIGNS OF NO FLOW WERE OBSERVED. THE NURSE THEN CHECKED THE PATIENT'S VEIN ACCESS SITE AND AGAIN NO RESTRICTION OF FLOW WAS OBSERVED. THE DEVICE WAS LEFT CONNECTED TO THE PATIENT FOR ANOTHER 24 HOURS, AFTER WHICH TIME THE DEVICE WAS REPORTED TO STILL NOT HAVE EMPTIED. THE REPORTER ESTIMATED THAT THERE WAS 50 ML OF SOLUTION LEFT IN THE DEVICE. 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
    406336 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13M060

    Patients

    Seq Age Sex Outcome Treatment
    1 PORT-A-CATH| FLUOROURACIL