BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2161547 · Received July 14, 2011

    Report

    Report Number
    6000001-2011-11840
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 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). 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 IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF DELIVERY STOPPED WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE DEVICE SHOWED NO SIGNS OF BLOCKAGE THAT COULD HAVE CAUSED THE REPORTED CONDITION. AN ACCURACY FLOW TEST WAS PERFORMED ON THE SAMPLE FOR 42 HOURS. AT THE END OF THE FLOW TEST PERIOD, THE INFUSOR PRODUCED THE FOLLOWING FLOW RATES: CALCULATED FLOW RATE = 1.93 ML/HR, NORMALIZED FLOW RATE = 1.98 ML/HR, SPECIFICATION RANGE = 1.80 - 2.20 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. 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD DELIVERY STOP DURING PATIENT AT-HOME USE. THE DEVICE WAS FILLED WITH A SOLUTION OF 5-FLUOROURACIL AND SALINE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY. 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 10J016

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| 5-FLUOROURACIL