BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESUITE ED PULSECHECK

    MDR report key: 1713653 · Received June 7, 2010

    Report

    Report Number
    3005244943-2010-00002
    Event Type
    Injury
    Date Received
    June 7, 2010
    Report Date
    May 5, 2010
    Manufacturer
    PICIS, INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION FOUND THAT THE REASON FOR NO ALLERGY INTERACTION NOTIFICATION WAS A RESULT OF RECEIVING CODED ALLERGIES FROM A NON-SUPPORTED EXTERNAL DRUG DATABASE SOURCE. THE ALLERGY DATA IN QUESTION WAS RECEIVED BY PICIS' ED HEALTH RECORD APPLICATION IN 2006. IT IS CUSTOMARY IN HEALTHCARE APPLICATIONS FOR ALLERGY INFORMATION TO 'CARRY THROUGH' FROM VISIT TO VISIT. THE IMPORTANCE OF THIS IS THAT IN THE COURSE OF OUR INVESTIGATION, WE CONCLUDED THAT THIS CLIENT IS NO LONGER SENDING NON-SUPPORTED ALLERGY CODES AND HAS NOT DONE SO SINCE LATE 2008. PICIS IS WORKING WITH THE CUSTOMER TO REVIEW ALLERGY CODES SENT PRIOR TO 2008 TO ASCERTAIN IF THERE ARE ANY ADDITIONAL ERRONEOUS ALLERGY CODES STORED IN THE DATABASE. ADDITIONALLY, DURING THE COURSE OF OUR INVESTIGATION, WE IDENTIFIED TWO SIMILAR CUSTOMER SITE CONFIGURATIONS WITH NON-SUPPORTED DRUG DATABASES. THERE WERE NO ASSOCIATED PT INCIDENT REPORTS. HOWEVER, WE ARE WORKING WITH THESE CUSTOMERS TO PREVENT UNSUPPORTED ALLERGY CODES FROM BEING SENT TO THE PICIS APPLICATION. PICIS IS ALSO EXPLORING THE POTENTIAL FOR SIMILAR SYSTEM ADMINISTRATION ERROR IN OTHER SITES. WE WILL EVALUATE THE NEED FOR CORRECTIVE ACTION AND IMPLEMENT ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PT INCIDENT INVOLVING PICIS' ED (EMERGENCY DEPT.) ELECTRONIC HEALTH RECORD APPLICATION RELATED TO ALLERGY DATA RECEIVED VIA INTERFACE FROM THEIR ENTERPRISE INFORMATION SYSTEM, WHICH WAS 'CODED' USING A 3RD PARTY DRUG DATABASE TERMINOLOGY NOT SUPPORTED BY PICIS. THE NUMERIC CODE REPRESENTING 'SULFONAMIDES' IN THE ENTERPRISE SYSTEM REPRESENTS A DIFFERENT ALLERGY CONCEPT (METHYLXANTHINES) IN PICIS' SUPPORTED THIRD PARTY DRUG DATABASE. THE SCREEN DISPLAYED THE CORRECT ALLERGY NAME OF SULFONAMIDES TO THE PHYSICIAN, BUT THE BACKGROUND ALLERGY CHECKING LOGIC (DETERMINED BY THE NUMERIC CODE SENT FROM THE INTERFACE) DID NOT NOTIFY THE PHYSICIAN OF A POTENTIAL ALLERGY INTERACTION, WHEN A PRESCRIPTION FOR BACTRIM WAS WRITTEN. THE PT WAS DISCHARGED FROM THE ED WITH THE WRITTEN PRESCRIPTION WHICH WAS LATER FILLED BY A RETAIL PHARMACIST. THE PT MANIFESTED SYMPTOMS OF AN ALLERGIC REACTION WITHIN 24 HOURS, WAS SEEN TWICE BY PHYSICIANS AND SENT HOME WITH OUTPATIENT TREATMENT BUT ULTIMATELY REQUIRED 48 HOURS OF INPATIENT OBSERVATION, BEFORE BEING DISCHARGED HOME WITH NO LONG TERM EFFECTS.

    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 Hospitalization MEDITECH SYSTEM