BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2231976 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22254
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHOTOGRAPH OF THE SAMPLE IS AVAILABLE FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED A PHOTO OF THE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A STRESS MEMBER WHICH SEPARATED FROM THE HOUSING 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. THE LOT NUMBER PROVIDED WAS INVALID. THEREFORE, A BATCH REVIEW COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD A SEPARATED STRESS MEMBER. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. 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 2010K18

    Patients

    Seq Age Sex Outcome Treatment
    1