BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICIS PERIOPERATIVE AND CRITICAL CARE

    MDR report key: 6139589 · Received December 1, 2016

    Report

    Report Number
    3005244943-2016-00001
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Report Date
    November 7, 2016
    Manufacturer
    PICIS CLINICAL SOLUTIONS, INC.
    Product Code
    NSX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE HAS BEEN DETERMINED TO POTENTIALLY AFFECT PICIS PERIOPERATIVE AND CRITICAL CARE VERSIONS 8.6 SERVICE PACK 4 AND 8.6 SERVICE PACK 5 WHEN BOTH PREOP MANAGER AND OR MANAGER ARE UTILIZED TOGETHER. A SOFTWARE SOLUTION HAS BEEN CREATED AND WILL BE MADE AVAILABLE TO POTENTIALLY AFFECTED CLIENTS AND INCLUDED IN A FUTURE 8.6 SERVICE PACK. ADDITIONALLY, THE ISSUE IS EXPERIENCED WHEN AN UNUSUAL CLIENT WORKFLOW IS FOLLOWED. ACCORDING TO CLINICAL REPRESENTATIVE FEEDBACK, IT IS NOT TYPICAL FOR CLIENTS TO ENTER PRECAUTIONS INTO PICIS PREOP MANAGER AHEAD OF A BOOKING BEING CREATED IN PICIS OR MANAGER. THE COMPANY REVIEWED RELATED USER DOCUMENTATION AND DETERMINED THE USER DOCUMENTATION MAY BE ENHANCED WITH A CAUTIONARY STATEMENT TO ENSURE CUSTOMERS ARE AWARE OF THE NEED TO CREATE A BOOKING IN PICIS OR MANAGER PRIOR TO THE PRECAUTIONS BEING ENTERED IN PICIS PREOP MANAGER. USER DOCUMENTATION WILL BE ENHANCED WITH THE RELEASE OF A FUTURE 8.6 SERVICE PACK.

    Description of Event or Problem · 1

    PICIS CLINICAL SOLUTIONS, INC. (PICIS) HAS RECEIVED AND INVESTIGATED A CUSTOMER REPORT OF AN INTEROPERABILITY ISSUE WITHIN THE PICIS PERIOPERATIVE AND CRITICAL CARE SOFTWARE APPLICATION. CUSTOMER REPORTED THAT A PRECAUTION ENTERED INTO PREOP MANAGER DID NOT FLOW TO THE OR MANAGER APPLICATION AS EXPECTED. THE INVESTIGATION INTO THE REPORTED INCIDENT CONCLUDED THAT THE ROOT CAUSE RESULTED IN THE SOFTWARE NOT CAPTURING THE PRECAUTION IN OR MANAGER THAT WAS ENTERED INTO PREOP MANAGER. THE INVESTIGATION HAS IDENTIFIED AN ISSUE WHERE THE PICIS INTERMESSAGING SERVICE (PIMS) CHANNELS CREATE EXCESSIVE THREADS AND ADVERSELY IMPACT THE PICIS CONNECTIVITY MANAGER (PCM). AS A RESULT, MESSAGES MAY NOT BE PROCESSED AS EXPECTED (THE MESSAGE THAT LINKS THE PREADMISSION PATIENT AND THE PATIENT FROM THE BOOKING MAY NOT BE PROCESSED). OUR FINDINGS REVEALED THE UNIQUE SITUATION REPORTED BY THE COMPLAINANT OCCURS WHEN CLIENTS FOLLOW A PARTICULAR WORKFLOW. AFTER INTERNAL INVESTIGATION WITH CLINICAL RESOURCES, IT WAS DETERMINED THAT THE WORKFLOW UTILIZED BY THIS REPORTING CLIENT WAS NOT COMMON. REPORTING OF THIS CONDITION FROM CLIENTS IS RARE (ONLY ONE REPORTED CLIENT COMPLAINT TO DATE AFTER MORE THAN TEN YEARS ON THE MARKET), AS THE ISSUE IS ONLY EXPERIENCED WITH UNIQUE CONDITIONS AND WORKFLOWS. A SOFTWARE SOLUTION HAS BEEN DESIGNED TO ADDRESS THIS ISSUE. THE USER DOCUMENTATION WILL BE ENHANCED TO INCLUDE A CAUTIONARY STATEMENT REGARDING THE PROPER DATA WORKFLOW. EVENT DESCRIPTION CUSTOMER REPORT: "THIS PATIENT HAD A SLATE ALERT (OSAM) ENTERED IN POM (PICIS PREOP MANAGER) BY THE PSS RN YESTERDAY (B)(6) 2016 BUT DID NOT APPEAR ON THE SLATE TODAY (B)(6) 2016 AS SEEN BELOW. THE NURSE HAS NOW ENTERED THE ALERT IN ORM (PICIS OR MANAGER) AND THIS CARRIED OVER TO THE SLATE. WE NEED TO ENSURE THIS DOES NOT HAPPEN FOR SAFETY REASONS AS WE WERE UNDER THE UNDERSTANDING THAT WE ARE TO ENTER SLATE ALERTS IN POM (PICIS PREOP MANAGER) AND THESE WILL CARRY FORWARD TO THE SLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790883 PICIS PERIOPERATIVE AND CRITICAL CARE SOFTWARE, TRANSMISSION & STORAGE NSX PICIS CLINICAL SOLUTIONS, INC. 8.6

    Patients

    Seq Age Sex Outcome Treatment
    1