BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION 6000 PUMP

    MDR report key: 3131677 · Received May 6, 2013

    Report

    Report Number
    1722139-2013-00803
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT FLUID INGRESS INTO PUMP CAUSING PCB TO CORRODE AND UNABLE TO PERFORM TEST TO CONFIRM THE COMPLAINT. PCB WAS REPLACED AND PUMP WAS RECALIBRATED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER STATED THE PUMP OVER INFUSED DURING THE FIRST HOUR OF INFUSION. PUMP SHOULD HAVE INFUSED 0.9 ML PER HOUR WITH A BOLUS OF 1.5 ML. THE LOCKOUT SHOULD HAVE BEEN 30 MINUTES. PT RECEIVED 15.4ML WITH 9 BOLUS DOSES WITH 15 ATTEMPTS. RATE PROVIDED IS 0.9 ML. THERE IS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197766 CURLIN INFUSION 6000 PUMP FRN MOOG MED DEVICES GROUP 6000 PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR MORPHINE