BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURLIN 6000 CMS INFUSION PUMP

    MDR report key: 6141856 · Received December 2, 2016

    Report

    Report Number
    1722139-2016-00609
    Event Type
    Death
    Date Received
    December 2, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED PUMP WAS RETURNED TO MMDG, WHERE IT WAS EVALUATED. THE PUMP HISTORY WAS REVIEWED AND FUNCTIONAL AND FLOW TESTING WAS PERFORMED. MMDG COULD FIND NO FAILURES WITH THE PUMP.

    Description of Event or Problem · 1

    MMDG RECEIVED AN EMAIL FROM THE INITIAL REPORTER REQUESTING THAT THE PUMP BE EVALUATED AND THE PUMP HISTORY REVIEWED TO ENSURE CORRECT OPERATION. THE PATIENT WAS IN HOSPICE AND HAD BEEN DISCHARGED WITH ORDERS FOR TPN AND MILRINONE, AND PASSED AWAY LATER THAT DAY. MMDG DID FOLLOW UP WITH THE INITIAL REPORTER, AND THEY DID STATE THAT THEY DID NOT BELIEVE THE PUMP HAD MALFUNCTIONED, BUT BECAUSE THE PATIENT HAD EXPIRED THEY WANTED TO HAVE THE PUMP REVIEWED TO ENSURE CORRECT OPERATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791233 CURLIN 6000 CMS INFUSION PUMP INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 360-1400P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Death