BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESUITE ED PULSECHECK

    MDR report key: 1700028 · Received May 25, 2010

    Report

    Report Number
    3005244943-2010-00001
    Event Type
    Other
    Date Received
    May 25, 2010
    Date of Event
    April 24, 2010
    Report Date
    April 27, 2010
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION INTO THE REPORTED INCIDENT HAS CONCLUDED THAT THE ROOT CAUSE RELATES TO USER ERROR. IN THE COURSE OF OUR INVESTIGATION AND FOLLOW-UP WITH THE CUSTOMER, IT WAS CONFIRMED THAT THE CLINICIAN MISREAD THE MEDICATION ORDER, AS DISPLAYED IN THE ED ELECTRONIC HEALTH RECORD APPLICATION. THE CLINICIAN WAS CONFUSED BY THE MEDICATION STRENGTH/CONCENTRATION DETAIL AS COMPARED TO THE DOSE IN THEIR CONFIGURED DISPLAY FORMAT. THE CUSTOMER REPRESENTATIVES WERE REMINDED OF THE OPTIONS AVAILABLE TO CONFIGURE THEIR DISPLAY FORMAT, IF THEY SO DESIRE TO NOT SHOW "STRENGTH" OR "DOSE FORM." THE CUSTOMER WAS ALSO REMINDED OF THE OPTION TO SET A POP-UP BOX WITH THE FIVE RIGHTS OF MEDICATION ADMINISTRATION RULE AS AN ADDITIONAL VERIFICATION STEP. THEY WERE VERY SATISFIED WITH PICIS RAPID RESPONSE AND INDICATED THAT THEY MUST DETERMINE AMONGST THEIR ED LEADERSHIP TEAM AND PHARMACIST, THE MOST APPROPRIATE DISPLAY FORMAT. PICIS HAS RE-EVALUATED THE MEDICATION SERVICES FEATURES IN OUR ED ELECTRONIC HEALTH RECORD DESIGN AND HAVE CONCLUDED THE DESIGN IS SAFE AND EFFECTIVE WHEN USED PROPERLY AND ACCORDING TO PUBLISHED DOCUMENTATION AND TRAINING. NO CORRECTIVE ACTIONS ARE WARRANTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT MEDICATION ERROR, RESULTING FROM A CLINICIAN'S CONFUSION AND INCORRECT INTERPRETATION OF THE MEDICATION ORDER WITHIN THE MEDICATION SERVICES DISPLAY OF PICIS' ELECTRONIC HEALTH RECORD APPLICATION. ALTHOUGH THE ORDER WAS WRITTEN AND DISPLAYED FOR INSULIN 100UNITS/ML SOLUTION - DOSE: 10 UNIT(S) IV, THE ERROR RESULTED WITH A PATIENT RECEIVING A DOSE OF INSULIN, 100 UNITS IV. THE CUSTOMER EXPLAINED THAT THE CLINICIAN THOUGHT THE DOSE SEEMED 'HIGH', BUT ALSO WORKS IN AN ICU WHERE SUCH A DOSE, WHILE VERY RARE, OCCASIONALLY OCCURS. FOLLOWING ADMINISTRATION OF THE ORDER, THE CLINICIAN WENT BACK TO THE MEDICATION SERVICES SCREEN TO REVIEW THE ORDER AND DOCUMENT THE ADMINISTRATION OF THE MEDICATION, AND AT THAT POINT THEY REALIZED THE MISTAKE. THE PATIENT HAD NO IMMEDIATE OR LONG TERM EFFECTS. THE PATIENT WAS GIVEN LUNCH AND MONITORED THROUGH FINGER STICKS TO MEASURE BLOOD SUGAR. BLOOD SUGAR NEVER WENT BELOW 200 AND THE PATIENT WAS DISCHARGED FROM THE ED ABOUT 4 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESUITE ED PULSECHECK S/W, TRANSMISSION & STORAGE PATIENT DATA NSX PICIS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other