BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ED PULSECHECK

    MDR report key: 5290728 · Received December 11, 2015

    Report

    Report Number
    3005244943-2015-00005
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Report Date
    November 18, 2015
    Manufacturer
    PICIS CLINICAL SOLUTIONS, INC.
    Product Code
    NSX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INVESTIGATION PICIS CLINICAL SOLUTIONS HAS CONFIRMED THE REPORTED DEFECT AND WILL BE PROVIDING A SOLUTION INA FUTURE ED PULSE CHECK SOFTWARE SOLUTION. A CAPA HAS BEEN INITIATED TO FURTHER ANALYZE THE ROOT CAUSE(S) OF THIS DEFECT AND TO IMPLEMENT CORRECTIVE ACTION AS NECESSARY. NO ADVERSE EVENTS HAVE BEEN ATTRIBUTED TO THIS ISSUE. CLINICAL REVIEW SUGGESTS THERE IS A POTENTIAL FOR ORDERING AND ADMINISTERING A MEDICATION THAT COULD INTERACT WITH A PATIENT'S CURRENT MEDICATIONS WITHOUT A NOTIFICATION BEING PROVIDED DUE TO THE OMISSION FROM THEIR CURRENT MEDICATION LIST. THE NATURE AND EXTENT OF ANY UNTOWARD OUTCOME WOULD BE DIRECTLY RELATED TO THE SEVERITY OF THE INTERACTION BETWEEN THE MEDICATION ORDERED AND THE HOME MEDICATION THAT IS OMITTED. THE ROOT CAUSE FOR CLINICIANS BEING UNABLE TO APPLY A MEDICATION TO A PATIENT VISIT HAS BEEN IDENTIFIED AND A SOFTWARE SOLUTION IS BEING DEVELOPED FOR THIS SPECIFIC CLIENT, WITH PLANS TO DISTRIBUTE TO THE ED PULSE CHECK CLIENT BASE AS PART OF A FUTURE SERVICE PACK AS A PREVENTIVE MEASURE TO REMOVE RISK ON SIMILAR INTERFACES THAT MIGHT BE DEPLOYED AT OTHER CLIENT SITES IN THE FUTURE.

    Description of Event or Problem · 1

    PICIS CLINICAL SOLUTIONS RECEIVED A CUSTOMER COMPLAINT ON (B)(6) 2015: WHEN A CURRENT MEDICATION IS SENT ON THE INBOUND ADT VIA A08, AND THE USER CLICKS 'N/A' INITIALLY, THAT MEDICATION IS NOT ABLE TO BE RE-ADDED EITHER THROUGH THE "SEARCH" OR QUICKLIST TO THE CURRENT VISIT. DURING THE INITIAL PATIENT TRIAGE INTERVIEW THE NURSE MARKS A SPECIFIC MEDICATION THAT HAS COME IN FROM PREVIOUS/EXTERNAL VIA ADT AS 'NA'. SO ASPIRIN 81 MG PO, FOR EXAMPLE, IS MARKED N/A BECAUSE THE PATIENT CLAIMS THEY ARE NOT TAKING THAT ANYMORE. SOMETIME LATER IN THE VISIT, THE PHARMACIST IS REVIEWING THE RECORD AND DETERMINES THAT ASPIRIN SHOULD IN FACT BE ACTIVE AS A CURRENT MEDICATION. THAT SPECIFIC MEDICATION IS NOT ABLE TO BE ADDED BACK TO THE CURRENT MEDS VISIT. IT ALLOWS YOU TO SELECT IT, BUT WHEN YOU FIND AND SUBMIT, THE SCREEN REFRESHES AND NOTHING GETS ENTERED. THE CLINICIAN IS ABLE TO ENTER THE MEDICATION AS FREE TEXT, HOWEVER SINCE THE MEDICATION IS NOT ENTERED AS STRUCTURED, THE ED PULSE CHECK APPLICATION WILL NOT PERFORM MEDICATION ALLERGY INTERACTION CHECKING. IT WAS DETERMINED THAT THIS ISSUE IS LIKELY CONTAINED TO ONE EXISTING CLIENT ON ED PULSE CHECK V5.4 DUE TO THEIR INTERFACE DESIGN AND CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819063 ED PULSECHECK SOFTWARE, TRANSMISSION AND STORAGE NSX PICIS CLINICAL SOLUTIONS, INC. 5.4

    Patients

    Seq Age Sex Outcome Treatment
    1