BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 2231973 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22252
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    March 23, 2011
    Report Date
    August 11, 2011
    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). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING NO FLUID IN THE RESERVOIR. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGN OF PHYSICAL ABNORMALITY. AN ACCURACY FLOW TEST WAS PERFORMED ON THE SAMPLE FOR 43.5 HOURS. AT THE END OF THE FLOW TEST PERIOD, THE FOLFUSOR PRODUCED THE FOLLOWING FLOW RATES: CALCULATED FLOW RATE = 4.84 ML/HR, NORMALIZED FLOW RATE = 4.96 ML/HR, SPECIFICATION RANGE = 4.50 ? 5.50 ML/HR. THE FOLFUSOR PRODUCED FUNCTIONAL RESULTS WITHIN THE SPECIFICATION RANGE; THE DEVICE PERFORMED AS EXPECTED. THE REPORTED CONDITION OF AN OVERINFUSION WAS NOT CONFIRMED. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, THIS PRODUCT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. A LABELING REVIEW FOUND THE DIRECTIONS FOR USE: MIXING AND USE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT A 5 ML/HR FOLFUSOR OVERINFUSED DURING PATIENT USE. THE TOTAL FILL VOLUME OF 243 ML WAS INFUSED OVER THE COURSE OF 24 HOURS RATHER THAN 48 HOURS. THIS IMPLIES A 10 ML/HR FLOWRATE, WHICH IS 200% OF THE EXPECTED FLOWRATE. THE DEVICE WAS FILLED WITH A 243-ML SOLUTION OF 4800 MG 5-FLUOROURACIL AND 800 MG ONCOFOLIC IN SALINE. INFUSION FLOW RATE GREATER THAN 130% OF EXPECTED RATE HAS THE POTENTIAL TO LEAD TO A SERIOUS INJURY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10K083

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR SALINE| 5-FLUOROURACIL| ONCOFOLIC