BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2900419 · Received January 7, 2013

    Report

    Report Number
    1416980-2013-00450
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE SAMPLE HAS BEEN MADE. SHOULD THE SAMPLE BE RECEIVED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON THE COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION WAS CONFIRMED VIA VISUAL EXAMINATION. THE ROOT CAUSE WAS DETERMINED TO BE OPERATOR ERROR DURING THE ASSEMBLY PROCESS; SPECIFICALLY, THE OPERATOR DID NOT TIGHTEN THE CAP HARD ENOUGH. AS A CORRECTIVE ACTION, AWARENESS TRAINING ON THIS ISSUE WAS PERFORMED IN JANUARY 2013. THE COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO AWARENESS TRAINING. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. ADDITIONAL INFORMATION: 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 CORPORATE PRODUCT SURVEILLANCE RECEIVED A REPORT FROM A BAXTER (B)(6) QUALITY SPECIALIST OF AN INFUSOR ON WHICH THE FILL PORT CAP WAS SEPARATED FROM THE FILL PORT. THIS ISSUE WAS OBSERVED BEFORE USE. THERE WAS NO REPORT OF ADVERSE EVENT, PATIENT INVOLVEMENT, PATIENT INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7556 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12J044

    Patients

    Seq Age Sex Outcome Treatment
    1