BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2212494 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-18990
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING SOLUTION IN THE RESERVOIR. THE REPORTED CONDITION OF AN UNDERINFUSION WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. FLOW WAS READILY OBSERVED AT THE LUER. THE SOLUTION IN THE BLADDER WAS ALLOWED TO DRAIN UNTIL EMPTIED. AN ACCURACY FLOW TEST WAS PERFORMED ON THE SAMPLE FOR 43.5 HOURS. AT THE END OF THE FLOW TEST PERIOD, THE UNIT PRODUCED THE FOLLOWING FLOW RATES: CALCULATED FLOW RATE = 4.91 ML/HR, NORMALIZED FLOW RATE = 5.03 ML/HR. SPECIFICATION RANGE = 4.50 ? 5.50 ML/HR. THE INFUSOR PRODUCED FUNCTIONAL RESULTS WITHIN THE SPECIFICATION RANGE; THE DEVICE PERFORMED AS EXPECTED. 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. ADDITIONAL INFORMATION: . PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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 AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT A 5 ML/HR LARGE VOLUME INFUSOR UNDERINFUSED DURING PATIENT USE. A VOLUME OF 120 ML WAS INFUSED OVER THE COURSE OF 60 HOURS RATHER THAN 24 HOURS. THIS IMPLIES A 2 ML/HR FLOWRATE, WHICH IS 40% OF THE EXPECTED FLOWRATE. THE DEVICE WAS FILLED WITH A 230-ML SOLUTION OF 5-FLUOROURACIL AND SALINE. INFUSION FLOW RATE LESS THAN 70% OF EXPECTED RATE COULD 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. THE SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11D088

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| 5-FLUOROURACIL