BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3900518 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20684
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). MANUFACTURE DATE: FEBRUARY 27, 2014 - MARCH 1, 2014. EVALUATION: THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS CURRENTLY AWAITING EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES. FUNCTIONAL FLOW TESTING DETERMINED THAT THE DEVICE FLOWED WITHOUT ISSUE. NO MALFUNCTIONS WERE IDENTIFIED DURING PRODUCT EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR STOPPED INFUSION AFTER 60 HOURS. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377573 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B043

    Patients

    Seq Age Sex Outcome Treatment
    1