BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2260632 · Received September 22, 2011

    Report

    Report Number
    6000001-2011-26369
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    September 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. 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. 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.

    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 INFUSOR PRODUCED THE FOLLOWING FLOW RATES: CALCULATED FLOW RATE = 4.89 ML/HR, NORMALIZED FLOW RATE = 5.01 ML/HR, SPECIFICATION RANGE = 4.50 - 5.50 ML/HR. THE INFUSOR 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. 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 A 5 ML/HR LARGE VOLUME INFUSOR OVERINFUSED DURING PATIENT USE. THE TOTAL FILL VOLUME OF 240 ML WAS INFUSED OVER THE COURSE OF 36 HOURS RATHER THAN 48 HOURS. THIS IMPLIES A 6.67 ML/HR FLOW RATE, WHICH IS 133% OF THE EXPECTED FLOW RATE. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. 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 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10B073

    Patients

    Seq Age Sex Outcome Treatment
    1