BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2823129 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04335
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING 188 ML OF 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 = 4.74 ML/HR, NORMALIZED FLOW RATE = 4.86 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 UNDERINFUSION 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.

    Description of Event or Problem · 1

    BAXTER CHINA RECEIVED A REPORT THAT A 5 ML/HR INFUSOR UNDERINFUSED DURING PATIENT USE. THE TOTAL FILL VOLUME WAS 240 ML AND THE DEVICE WAS EXPECTED TO INFUSE FOR 48 HOURS. AFTER 36 HOURS, 220 ML OF THE VOLUME REMAINED. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. 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 10F044

    Patients

    Seq Age Sex Outcome Treatment
    1