BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESUITE CRITICAL CARE MANAGER

    MDR report key: 1474582 · Received June 30, 2009

    Report

    Report Number
    3005244943-2009-00002
    Event Type
    Malfunction
    Date Received
    June 30, 2009
    Date of Event
    June 3, 2009
    Report Date
    June 3, 2009
    Manufacturer
    PICIS, INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT IS CURRENTLY UNDER INVESTIGATION. DETAILS SURROUNDING THE ERROR CONDITIONS AND PATIENT INCIDENT HAVE BEEN SLOWLY FORTHCOMING FROM THE USER FACILITY. WE ARE CONTINUING IN OUR EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER, TO AIDE IN OUR INVESTIGATION. THE RESULTS OF OUR INVESTIGATION WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IN CONNECTION WITH THE USE OF OUR CARESUITE FAMILY OF MEDICAL DEVICE DATA SYSTEMS, IT WAS REPORTED THAT ELECTRONIC DOCUMENTATION OF PRESCRIBED MEDICATION ORDERS WERE NOT DISCONTINUED FOLLOWING AN ORDER UPDATE TO PATIENT ELECTRONIC RECORDS. WHILE ATTEMPTING TO UPDATE ELECTRONIC RECORDS FOR THREE PATIENTS, A DOCTOR REPORTED THE FUNCTION TO DISCONTINUE MEDICATION ORDERS WAS NOT WORKING CORRECTLY. THE DOCTOR LEFT WRITTEN INSTRUCTIONS FOR THE NURSES. HOWEVER, THE NURSES DID NOT SEE THE INSTRUCTIONS AND CONTINUED MEDICATION ORDERS AS THEY APPEARED IN THEIR TASKS WINDOW FOR ADMINISTRATION OF MEDICATION ORDERS. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THREE PATIENTS CONTINUED TO RECEIVE MEDICATION ORDERS (GENTAMICINUM) BEYOND THE DOCTOR'S INSTRUCTION TO DISCONTINUE. NO IMMEDIATE PATIENT INJURY OCCURRED AND NO MEDICAL INTERVENTION TAKEN TO PREVENT INJURY, HOWEVER, THE CUSTOMER HAS NOT RULED OUT THE POTENTIAL FOR LONG-TERM INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NEONATE Other