BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESUITE PREOP MANAGER

    MDR report key: 1359124 · Received April 7, 2009

    Report

    Report Number
    3005244943-2009-00001
    Event Type
    Injury
    Date Received
    April 7, 2009
    Date of Event
    February 1, 2009
    Report Date
    March 13, 2009
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION INTO THE REPORTED INCIDENT REVOLVED AROUND HOW OUR MEDICAL DEVICE DATA SYSTEM INTERFACES WORK IN POPULATING CARESUITE END USER APPLICATIONS WITH HIS/CIS DATA. THE CARESUITE FAMILY APPLICATIONS ARE DELIVERED WITH 'STANDARD' LINKED ALLERGY FIELDS. BY DEFAULT, THESE FIELDS ARE CONFIGURED TO IMPORT DATA FROM OTHER VENDOR SYSTEMS, AND/OR TO TRANSFER DATA WITHIN THE CARESUITE APPLICATIONS. WHEN IMPLEMENTING THESE APPLICATIONS, SITES MUST DECIDE WHETHER THE HIS OR CARESUITE IS THE MASTER OF THE ALLERGY AND PRECAUTION DATA. DATA MUST NOT BE ENTERED THROUGH BOTH SYSTEMS IN ORDER TO MAINTAIN THE INTEGRITY OF THE DATA. THE SITUATION IS THAT PATIENT DEMOGRAPHIC DATA FIELDS FOR ALLERGIES AND PRECAUTIONS CAN BE ENTERED INTO CARE SUITE APPLICATIONS IN TWO WAYS: LOCALLY BY THE END USER OR EXTERNALLY VIA AN HIS/ADT INTERFACE. OUR METHODOLOGY IS THAT THE HIS IS THE DEFAULT MASTER. THE FOLLOWING SCENARIO IS POSSIBLE: PATIENT IS BOOKED TO GO INTO THE OR. IN THE PREOP APPLICATION, THE PRE OP NURSE ENTERS AN ALLERGY. PATIENT RECORD IS STARTED IN ANESTHESIA AND THE ADT INTERFACE DOWNLOADS ALLERGY INFORMATION FROM THE HIS. IF THE INFORMATION IS THE SAME, THEN THERE IS NO PROBLEM. HOWEVER, IF THE HIS ALLERGY FIELD IS BLANK OR DIFFERENT, IT WILL OVERWRITE THE END USER ALLERGY FIELD ENTERED IN THE PREOP APPLICATION (E.G. REMOVE AN UPDATED ALLERGY, LEAVE IT BLANK OR DIFFERENT). IT IS CURRENTLY POSSIBLE TO CONFIGURE THE SYSTEM TO PREVENT THIS, AND MANY CUSTOMERS UNDERSTAND THAT THE HIS IS THE MASTER BY DEFAULT, BUT IT IS POSSIBLE FOR THIS SEQUENCE OF EVENTS TO OCCUR. THROUGH OUR CLINICAL TRAINING AND IMPLEMENTATION, PICIS REVIEW WITH CUSTOMERS HOW THEY WANT TO CONFIGURE ALLERGIES. THIS REVIEW INCLUDES THE FACT THAT INTERFACE DATA FROM AN HIS WILL OVERWRITE THE DATA ENTERED INTO OUR APPLICATIONS. MOST CUSTOMERS DECIDE NOT TO BRING ALLERGIES IN THROUGH THE INTERFACE DATABASE. HOWEVER, IF THE ALLERGY FIELDS ARE NOT DE-LINKED FROM THE INTERFACE, THE DESCRIBED SCENARIO IS POSSIBLE. IN DEVELOPING OUR CORRECTIVE ACTION STRATEGY, WE HAVE REVIEWED CUSTOMER CONFIGURATION PROFILES, AND EVALUATED THE LEVEL OF RISKS ASSOCIATED WITH USAGE MODELS. THROUGH MORE DETAILED UNDERSTANDING OF CUSTOMER CONFIGURATIONS, PICIS HAS DEVELOPED A STRATEGY FOR RECOMMENDED SYSTEM INTERFACE RECONFIGURATION, TO MEET OUR CUSTOMER NEEDS. TO HELP ENSURE THE MOST APPROPRIATE CONFIGURATION AND INTEGRITY OF PATIENT DATA, WE HAVE INITIATED A CUSTOMER COMMUNICATION TO OUR INSTALLED BASE, EXPLAINING THE POTENTIAL SOURCE OF PATIENT DATA CONFLICT AND TO PROVIDE SUPPORT IN CHOOSING THE APPROPRIATE CONFIGURATION OPTION AND IMPLEMENTATION.

    Description of Event or Problem · 1

    IN CONNECTION WITH THE USE OF THE CARESUITE FAMILY OF MEDICAL DEVICE DATA SYSTEMS, IT WAS REPORTED THAT MANUAL PATIENT ALLERGY DATA ENTRIES INTO OUR END USER APPLICATION WERE OVERWRITTEN DURING AUTOMATIC UPDATES OF PATIENT DATA FROM THE HOSPITAL INFORMATION SYSTEM. THIS CONFIGURATION CONTRIBUTED TO A PATIENT INCIDENT, RESULTING IN A TEMPORARY ALLERGIC REACTION (SHORTNESS OF BREATH) TO A PRESCRIBED MEDICATION ORDER OF TORADOL. THE INCIDENT WAS MITIGATED THROUGH NORMAL CLINICAL PRACTICE. THE PATIENT WAS ABLE TO PROCEED WITH THEIR SCHEDULED SURGERY, WITHOUT FURTHER EFFECTS. AN IMPROPER CONFIGURATION OF THE INTERFACE DATABASE CONTRIBUTED TO THE INCIDENT, BY ALLOWING AUTOMATIC THIRD PARTY HIS/CIS UPDATES TO THE END USER APPLICATION, WHERE MANUAL UPDATES ARE IN PRACTICE. CUSTOMERS PREFERRING THIS PRACTICE SHOULD NOT LINK THE INTERFACE DATABASE TO THEIR HIS/CIS. THE REPORTING CUSTOMER SITE HAS BEEN RECONFIGURED TO SUPPORT THEIR PREFERRED PRACTICE. THERE HAVE BEEN NO OTHER REPORTS OF ADVERSE PATIENT IMPACT ASSOCIATED WITH THIS ISSUE. NONETHELESS, DURING THE COURSE OF OUR CURRENT INVESTIGATION WE'VE RECEIVED ONE ADDITIONAL SITE REPORT OF ALLERGY DATA BEING OVERWRITTEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other