BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN 4000 CMS AMBULATORY INFUSION PUMP

    MDR report key: 1058261 · Received June 9, 2008

    Report

    Report Number
    2031921-2008-00016
    Event Type
    Other
    Date Received
    June 9, 2008
    Date of Event
    May 8, 2008
    Report Date
    June 6, 2008
    Manufacturer
    CURLIN MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WILL NOT RELEASE THE PUMP TO CURLIN. IF IT IS RETURNED, CURLIN MEDICAL WILL EVALUATE THE PUMP. IT IS REPORTED THAT: ON JUNE 2, 2008, RN, BXN FROM CURLIN MEDICAL, MET WITH BIOMEDICAL ENGINEERING. WITH THE DOOR IN THE CLOSED POSITION, THE DOOR WAS BENT INWARD AND THE CLIP APPEARED RAISED UP ON THE TOP OF THE PUMP. THE DOOR WAS NOT FLUSH ACROSS THE TOP IN THE CLOSED POSITION. THERE WAS RESISTANCE AND RUBBING WHEN CLOSING THE DOOR. THE PUMP WAS TESTED USING THE ORIGINAL PROGRAM AT 10ML PER HOUR USING THE REPEAT THERAPY FUNCTION. DURING THIS TEST, IT APPEARED THAT THE DRIP RATE COMING FROM THE TUBING AND EMPTYING FROM THE SYRINGE WAS FASTER THAN 10 ML PER HOUR. BIOMED ENGINEERING AND RN WERE BOTH IN AGREEMENT WITH ALL VISUAL FINDINGS AND OBSERVATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED AN OVER INFUSION THAT PRESUMABLY OCCURRED ON MAY 7 INVOLVING 280 ML OF AA FENTANYL - ATIVAN MIX, PROGRAMMED TO INFUSE AT 10 ML PER HOUR. WITHIN AN HOUR IT WAS NOTICED THAT THE ENTIRE BAG HAD INFUSED. THE PT SUFFERED NO HARM, AND MEDICAL INTERVENTION WAS NOT REQUIRED. IT IS REPORTED THAT THE DOOR OF THE PUMP APPEARED ASKEW/DAMAGED. HE ALSO REPORTED THAT THE ORIGINAL BAG AND SET HAD BEEN RETAINED WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN 4000 CMS AMBULATORY INFUSION PUMP 4000 CMS FRN CURLIN MEDICAL 350-1101 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1