BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3170718 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15409
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR DID NOT FLOW WHEN ATTEMPTING TO DRAIN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271905 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12M004

    Patients

    Seq Age Sex Outcome Treatment
    1