BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2903660 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00594
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE USED SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGN OF PHYSICAL ABNORMALITY. AN ACCURACY FLOW TEST WAS PERFORMED ON THE SAMPLE. AT THE END OF THE FLOW TEST PERIOD, THE PCM PRODUCED THE A FLOW RATE OF 1.91 ML/HR. THE SPECIFICATION RANGE IS 1.80 - 2.20 ML/HR. THE PCM PRODUCED FUNCTIONAL RESULTS WITHIN THE SPECIFICATION RANGE; THE DEVICE PERFORMED AS EXPECTED. DURING THE FUNCTIONAL TEST, FLOW WAS NOT OBSERVED AT THE DISTAL LUER WITHOUT PUSHING THE PCM BUTTON. FLOW WAS ONLY OBSERVED AT THE DISTAL LUER WHEN THE PCM BUTTON WAS PUSHED. THE REPORTED CONDITION OF FREE FLOW 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. THIS PRODUCT IS NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER. 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 (B)(4) RECEIVED A REPORT THAT AN INFUSOR PATIENT CONTROL MODULE (PCM) KEPT FLOWING, WITHOUT PUSHING THE PCM BUTTON, FROM THE DISTAL LUER BEFORE USE. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10616 INFUSOR PUMP, INFUSION, PCA MEA BAXTER HEALTHCARE - IRVINE 12F036

    Patients

    Seq Age Sex Outcome Treatment
    1