BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2780744 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-01970
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    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. BAXTER RECEIVED A PHOTO OF THE SAMPLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED A PHOTO OF THE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS CONFIRMED VIA PHOTOGRAPHIC EVALUATION. THE ROOT CAUSE COULD NOT BE DETERMINED, AS THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL OBSERVATION WAS NOTED FROM THE PHOTO. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR LEAKED AT THE RESERVOIR BEFORE USE. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY. 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
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12C077

    Patients

    Seq Age Sex Outcome Treatment
    1