BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURLIN 6000 CMS INFUSION PUMP

    MDR report key: 6097186 · Received November 11, 2016

    Report

    Report Number
    1722139-2016-00597
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 12, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MMDG AND EVALUATED FOR THE FREE FLOW COMPLAINT. THE PUMP DID PASS VOLUMETRIC TESTING AS WELL AS 40PSI BACK PRESSURE TEST DURING THE FUNCTIONAL TEST. THE 40PSI TEST IS THE TEST THAT CHECKS FOR FREE FLOW. MMDG WAS UNABLE TO REPLICATE THE FREE FLOW EVENT OR CONFIRM THE COMPLAINT. THE PUMP IS OPERATING WITHIN PRODUCT SPECIFICATIONS. THE PUMP WILL BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT "THE PUMP DELIVERED MORE THAN PROGRAMMED." THEY STATE THAT THEY CHECKED THE PUMP SETTINGS AND THEY WERE CORRECT, BUT THE TUBING WAS KINKED IN THE CHAMBER. THERE WAS NO BASAL RATE SET AND NO BOLUSES HAD BEEN REQUESTED FOR ABOUT THREE HOURS. THE INITIAL REPORTER ALSO STATED THAT THE PATIENT HAD TWO DOSES OF NARCAN ADMINISTERED BECAUSE OF THE OVER SEDATION. MMDG DID FOLLOW UP WITH THE INITIAL REPORTER, WHERE IT WAS CONFIRMED THAT THE PATIENT HAD NOT HAD ANY PROLONGED STAY IN THE HOSPITAL, AND WAS DOING FINE. THEY WERE TRANSFERRED TO THE ICU AFTER THE EVENT, BUT WAS TRANSFERRED BACK OUT THE NEXT DAY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746183 CURLIN 6000 CMS INFUSION PUMP INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 360-1400P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention