BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2894984 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00146
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 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 PATIENT CONTROL MODULE (PCM) FOR EVALUATION. THE REPORTED CONDITION WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE DEVICE SHOWED NO SIGNS OF ABNORMALITY ON THE WHITE BUTTON THAT COULD HAVE CAUSED THE REPORTED CONDITION. A FUNCTIONAL FLOW TEST WAS PERFORMED. FLOW WAS ALSO READILY OBSERVED WHEN THE PCM'S BUTTON WAS PRESSED WITH AN AVERAGE DISPENSED VOLUME OF 1.96 ML. THE AVERAGE DISPENSED VOLUME WAS FOUND TO BE WITHIN SPECIFICATION (1.80-2.20 ML). DURING FUNCTIONAL TESTING, THE WHITE BUTTON CAME BACK UP AFTER IT WAS PUSHED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR PATIENT CONTROL MODULE (PCM) BUTTON WOULD STAY PUSHED DOWN DURING PATIENT USE. 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
    2607 INFUSOR PUMP, INFUSION, PCA MEA BAXTER HEALTHCARE - IRVINE 12E004

    Patients

    Seq Age Sex Outcome Treatment
    1