BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 4000 CMS INFUSION PUMP

    MDR report key: 6017048 · Received October 11, 2016

    Report

    Report Number
    1722139-2016-00571
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MMDG FOR EVALUATION AND IS NOT EXPECTED TO BE RETURNED. BECAUSE THE ACTUAL DEVICE COULD NOT BE INSPECTED, MMDG HAS BEEN UNABLE TO CONFIRM THE COMPLAINT.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATES THE PUMP WAS "REPLACE SET 4 AND DOWN OCCLUSION ". THEY WERE NOT ABLE TO RESOLVE THE ALARM. DURING A FOLLOW UP CALL, THE INITIAL REPORTER INDICATED THAT THE PATIENT MISSED FOUR ANTIBIOTIC DOSES WHILE WAITING FOR THEIR HOME CARE PHARMACY TO DELIVER A REPLACEMENT PUMP. THEY ALSO REPORTED THAT THERE WAS NO HARM OR ADVERSE EVENTS AS A RESULT OF THIS DELAY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668155 CURLIN 4000 CMS INFUSION PUMP INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 350-1100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT PROVIDED