BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURLIN 6000 CMS INFUSION PUMP

    MDR report key: 5732949 · Received June 17, 2016

    Report

    Report Number
    1722139-2016-00485
    Event Type
    Death
    Date Received
    June 17, 2016
    Date of Event
    May 18, 2016
    Report Date
    May 19, 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
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED PUMP HAS ARRIVED AT MMDG AND IS CURRENTLY BEING EVALUATED. NO RESULTS WERE AVAILABLE AT THE TIME OF THIS FILING. MMDG WILL FOLLOW UP AS RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INVOLVED PUMP WAS SENT TO MMDG TO HAVE THE PUMP HISTORY DOWNLOADED AND TO HAVE ITS PERFORMANCE EVALUATED. DURING THE EVALUATION THE PUMP WAS FOUND TO BE OPERATING AS PROGRAMMED AND WITHIN PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    MMDG WAS CONTACTED WITH A REQUEST TO DOWNLOAD THE INTERNAL EVENT LOG OF A PUMP THAT MAY HAVE BEEN INVOLVED WITH THE PASSING OF A PATIENT. THE PATIENT HAD BEEN IN THE HOSPITAL AT THE TIME. ACCORDING TO THE INITIAL REPORTER, THE PUMP WAS PROVIDED TO THE PATIENT AND PROGRAMMED TO DELIVER HYDROMORPHONE AT A STANDARD BAG SIZE AND DOSE FOR THE MEDICAL SITUATION. THE PATIENT PASSED AWAY A FEW HOURS AFTER THE PUMP WAS SET UP. THE INITIAL REPORTER STATED THAT THEY WERE UNSURE THAT THE PUMP WAS INVOLVED IN THE PATIENTS PASSING. [(B)(4)]

    Description of Event or Problem · 1

    MMDG WAS CONTACTED WITH A REQUEST TO DOWNLOAD THE INTERNAL EVENT LOG OF A PUMP THAT MAY HAVE BEEN INVOLVED WITH THE PASSING OF A PATIENT. THE PATIENT HAD BEEN IN THE HOSPITAL AT THE TIME. ACCORDING TO THE INITIAL REPORTER, THE PUMP WAS PROVIDED TO THE PATIENT AND PROGRAMMED TO DELIVER HYDROMORPHONE AT A STANDARD BAG SIZE AND DOSE FOR THE MEDICAL SITUATION. THE PATIENT PASSED AWAY A FEW HOURS AFTER THE PUMP WAS SET UP. THE INITIAL REPORTER STATED THAT THEY WERE UNSURE THAT THE PUMP WAS INVOLVED IN THE PATIENT'S PASSING. THIS FOLLOW-UP IS BEING FILED TO INCLUDE THE RESULTS OF THE DEVICE EVALUATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387686 CURLIN 6000 CMS INFUSION PUMP INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 360-1400P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death