BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURLIN INFUSION 4000CMS IV PUMP

    MDR report key: 1982232 · Received January 24, 2011

    Report

    Report Number
    1722139-2011-00003
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 21, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PATIENT HISTORY LOG WAS REVIEWED THOROUGHLY TO EVALUATE THE USER DECISIONS BY REVIEWING THE KEY PRESSES AND WHAT THERAPIES WERE DELIVERED AND WHEN. ATTEMPTED TO DUPLICATE THE "LOST PROGRAMMING" COMPLAINT BY PROGRAMMING A TPN THERAPY, RUNNING AND STOPPING THE THERAPY, PROGRAMMING AND RUNNING A CONTINUOUS THERAPY AND THEN TRYING TO FIND THE PREVIOUS TPN PROGRAM TO VERIFY IT WAS NOT LOST. CONCLUSION: COULD NOT DUPLICATE THE LOST PROGRAMMING COMPLAINT. THE PUMP PROGRAMMING FUNCTIONED AS DESIGNED AND THE TPN PROGRAM WAS ABLE TO BE FOUND. IT APPEARS THAT THE CUSTOMER WAS CONFUSED ABOUT THE INTENDED 920ML THERAPY AND WHY IT ENDED AT 919.3ML. THE THERAPY ENDED .7ML EARLY BECAUSE THAT WAS THE ACTUAL DOSE TO BE DELIVERED BECAUSE THE REQUIRED FIELDS THE USER ENTERED WAS 24:00 HOURS RUNTIME AND 38.333333 ML/HR RATE, WHICH WOULD DELIVER A 920ML DOSE, BUT IT WOULD TAKE 24 HOURS, 01 MINUTE. BECAUSE THE MAX TIME TO DELIVER IS 24 HOURS, 00 MINUTES, THE DOSE TO BE DELIVERED AUTO CALCULATED TO 919.3ML. IT APPEARS THAT THE CUSTOMER THOUGHT THE PROGRAM WAS LOST WHEN IN REALITY THE DOSE WAS SIMPLY DONE AND THE THERAPY WAS COMPLETE. ACCORDING TO THE COMMUNICATIONS WITH THE PHARMACY DIRECTOR, THE CAUSE FOR HYPOGLYCEMIA WAS PROGRAMMING ERROR. A 0.4ML/HR THERAPY WAS PROGRAMMED WHEN IT WAS INTENDED TO BE 40ML/HR. FIND ATTACHED THE FAILURE INVESTIGATION FORM FOR MORE DETAILS OF THE INVESTIGATION, WHICH INCLUDES A DETAILED REVIEW OF THE PATIENT HISTORY LOG.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: TPN WAS PROGRAMMED TO DELIVER 920 ML OVER 24 HOURS. BAG CONTAINED 14% DEXTROSE. WAS EXPERIENCING SOME ALARMS AND AT ONE POINT THE PUMP WAS INFUSING VIA CONTINUOUS MODE, WHICH WAS SET PREVIOUSLY AT 125ML/HR FOR FOUR MINUTES. THEN THEY REPROGRAMMED THE PUMP TO INFUSE OVER 24 HRS AT 0.4ML/HR. NOT SURE HOW THE TPN PROGRAM DISAPPEARED FROM THE PUMP. PHARMACIST WANTS TO KNOW WHERE DID THE TPN PROGRAM GO? PT WENT TO HOSPITAL FOR HYPOGLYCEMIA (LOW BLOOD SUGAR) ON (B)(6) 2010, AND THOUGH THE HYPOGLYCEMIA HAD BEEN CORRECTED THE LENGTH OF STAY IS EXTENDED DUE TO OTHER REASONS UNRELATED TO THE INFUSION. SHE REMAINS HOSPITALIZED DUE TO HER SOCIAL HISTORY, NOT DUE TO ILLNESS RELATED TO REASON FOR TPN ADMINISTRATION. A COPY OF THE PT HISTORY WILL BE SENT IN ALONG WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN INFUSION 4000CMS IV PUMP FRN MOOG MEDICAL DEVICES GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Hospitalization| R