BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2170414 · Received July 20, 2011

    Report

    Report Number
    6000001-2011-13234
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 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.ADDITIONAL NARRATIVE:A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. 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 CONTAINING NO SOLUTION IN THE RESERVOIR AND WITH A CONNECTED PATIENT CONTROL MODULE (PCM) WATCH. THE REPORTED CONDITION OF AN UNDERINFUSION WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLES SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. AN ACCURACY FLOW TEST WAS PERFORMED ON THE SAMPLE FOR 48 HOURS. AT THE END OF THE FLOW TEST PERIOD, THE INFUSOR PRODUCED THE FOLLOWING FLOW RATES: CALCULATED FLOW RATE, BASAL = 0.4623 ML/HR; CALCULATED FLOW RATE, BOLUS = 0.4900 ML/HR. NORMALIZED FLOW RATE, BASAL = 0.4738 ML/HR; NORMALIZED FLOW RATE, BOLUS = 0.5023 ML/HR. PCM WATCH AVERAGE DISPENSED VOLUME = 0.492 ML. SPECIFICATION RANGE, BASAL AND BOLUS = 0.4375 - 0.5625 ML/HR. SPECIFICATION RANGE, PCM WATCH = 0.425 - 0.580 ML. BOTH THE INFUSOR AND THE PCM 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 A 0.5 ML/HR INFUSOR OVERINFUSED DURING PATIENT USE. THE DEVICE WAS FILLED WITH A 12-ML SOLUTION OF 0.85 ML MORPHINE HYDROCHLORIDE, 1.8 ML LIDOCAINE, AND 9.35 ML SALINE. THE ENTIRE FILL VOLUME INFUSED OVER 12 HOURS, INDICATING A 1 ML/HR FLOWRATE. 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. 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 10D060

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| LIDOCAINE| MORPHINE HYDROCHLORIDE