BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURLIN INFUSION 4000CMS IV PUMP

    MDR report key: 1700954 · Received May 25, 2010

    Report

    Report Number
    1722139-2010-00064
    Event Type
    Death
    Date Received
    May 25, 2010
    Date of Event
    April 7, 2010
    Report Date
    May 24, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY LOG WAS REVIEWED BY MOOG CLINICAL STAFF AND DETERMINED THAT NO ALARMS OR ERRORS OCCURRED. THERE WAS NOTED BY THE CLINICAL REP, MANY INSTANCES OF BOLUS REQUESTS AND PRIMING. CONCLUSION: THE PUMP FUNCTIONED PER SPECS AND PASSED ALARM AND ACCURACY TESTS.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: INITIALLY REPORTED TO MOOG AS A REQUEST TO REVIEW THE PT/PUMP HISTORY LOG. AFTER TALKING WITH MOOG, IT WAS DECIDED THAT THE DEVICE SHOULD BE RETURNED FOR EVAL. PT INJURY? YES, PT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN INFUSION 4000CMS IV PUMP FRN MOOG MEDICAL DEVICES GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death