BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESUITE ED PULSECHECK

    MDR report key: 1725683 · Received June 10, 2010

    Report

    Report Number
    3005244943-2010-00003
    Event Type
    Other
    Date Received
    June 10, 2010
    Report Date
    May 14, 2010
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PICIS' INVESTIGATION INTO THE REPORTED INCIDENT IS BASED ON A LIMITED EXCHANGE OF INFO WITH THE CUSTOMER, AS WELL AS OUR INTERNAL REVIEW OF THE APPLICATION DESIGN AND CURRENT CONFIGURATION IN USE AT THE REPORTING SITE. REVIEW OF CONFIGURATION FILES, EXISTING SYSTEM BUILD AT THE CLIENT SITE, INTERFACE SPECIFICATION DOCUMENTS AND PREVIOUS CUSTOMER COMMUNICATIONS DEMONSTRATE THAT THE CUSTOMER IMPLEMENTED AND ACCEPTED THE PICIS EDIS IN 2008. DURING THIS PROCESS, THE PICIS EDIS SYSTEM WAS CONFIGURED TO DISPLAY ALL RESULTS SENT FROM THE CUSTOMER'S ENTERPRISE SYSTEM RATHER THAN CONFIGURING THE RESULTS DISPLAY IN 'OVERWRITE' MODE. PRIOR TO ACCEPTANCE, AN INVESTIGATION BY PICIS AND THE CLIENT REVEALED THAT IT WAS THE SENDING SYSTEM, SENDING MULTIPLE DUPLICATE RESULTS MESSAGES AND A REQUEST WAS MADE BY THE CUSTOMER OF THAT ENTERPRISE VENDOR TO INVESTIGATE. HOWEVER, DUE TO THE ENTERPRISE SYSTEM'S PROTOCOL FOR 'ADD ON' TESTS, IT WAS NOT POSSIBLE TO UTILIZE THE 'OVERWRITE' CONFIGURATION DUE TO THE RISK OF FILTERING OUT UNIQUE RESULTS AND SUBSEQUENTLY NOT PRESENTING THE CLINICIANS WITH IMPORTANT INFO. THEREFORE, THE CUSTOMER ELECTED TO HAVE ALL RESULTS DISPLAYED. HOSPITALS ALSO ARE REQUIRED TO HAVE ADD'L SAFEGUARDS IN PLACE FOR THE HANDLING OF CRITICAL RESULTS INCLUDING EXPEDITED REPORTING OF CRITICAL RESULTS WITH A LICENSED RESPONSIBLE CAREGIVER RATHER THAN RELYING SOLELY ON STANDARD RESULTS REPORTING PROCESSES (JOINT COMMISSION NATIONAL PATIENT SAFETY GOAL 02.03.01). THE CUSTOMER IS CURRENTLY WORKING WITH A 3RD PARTY INTEGRATION CONSULTANT TO IMPROVE THE HANDLING OF RESULTS SENT TO PICIS' ELECTRONIC HEALTH RECORD APPLICATION. WE ARE PROVIDING SUPPORT AS IT IS REQUESTED. AT THIS TIME, NO CORRECTIVE ACTION IS NEEDED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED A PATIENT INCIDENT THAT HAS PROMPTED A REVIEW OF THEIR INTERNAL PROCESS AND POSSIBLE ISSUES SURROUNDING THE INCIDENT. THE CUSTOMER REPORT ALLEGES THE INVOLVEMENT OF PICIS' ED (EMERGENCY DEPT.) ELECTRONIC HEALTH RECORD APPLICATION, WHEREBY, DUPLICATE RESULTS WERE RECEIVED BY THE PICIS EHR APPLICATION FROM AN ENTERPRISE INFO SYSTEM, WHICH, WHEN DISPLAYED IN THEIR ENTIRETY MAY HAVE CONTRIBUTED TO SOME DEGREE OF CONFUSION FOR THE TREATING PHYSICIAN - THE CONTEXT OF WHICH THE CUSTOMER HAS DECLINED TO CLARIFY ANY FURTHER. AT THIS TIME, WE HAVE BEEN INFORMED BY THE CUSTOMER THAT THEY ARE RESTRICTED BY SENIOR LEADERSHIP FROM DISCLOSING ANY SPECIFIC DETAILS REGARDING THE PATIENT'S STATUS, THE SPECIFIC TYPE OF RESULT OR EVIDENCE OF APPLICATION PERFORMANCE TO SUPPORT PICIS' INVESTIGATION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention