BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTUM PERIOPERATIVE AND CRITICAL CARE

    MDR report key: 3869053 · Received April 30, 2014

    Report

    Report Number
    3005244943-2014-00001
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    OPTUM CLINICAL SOLUTIONS, INC.
    Product Code
    NSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION INTO THE REPORTED INCIDENT CONCLUDED THAT THE ROOT CAUSE RESULTED IN THE SOFTWARE ALLOWING FOR A WORKFLOW FOR WHICH THE OPTUM PERIOP AND CRITICAL CARE SUITE (ELECTRONIC HEALTH RECORD) SOFTWARE APPLICATION IS NOT DESIGNED. OUR FINDINGS REVEALED THIS UNIQUE SITUATION ONLY OCCURS WHEN CLIENTS FOLLOW A PARTICULAR WORKFLOW. THIS WORKFLOW REQUIRES A COLLECTION OF STEPS THAT MUST BE FOLLOWED IN SEQUENTIAL ORDER IN ORDER FOR THIS SITUATION TO ARISE. 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. OPTUM CLINICAL SOLUTIONS WILL BE SENDING OUT A COMMUNICATION TO ANY CLIENTS THAT MAY BE POTENTIALLY AFFECTED ABOUT THE POSSIBILITY OF EXPERIENCING THIS SITUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORT: "WE GAVE A PATIENT A DRUG THAT THEY WERE ALLERGIC TO TODAY BECAUSE THE PCM DELETED THE DRUG. PLEASE SEE THE AUDIT TRAIL." AFTER INVESTIGATION, THE INCIDENT INVOLVED THE PREOP MANAGER AND OPERATING ROOM MANAGER (OR MANAGER), AN ELECTRONIC HEALTH RECORD SOFTWARE APPLICATION, WHEREBY THE UPDATED INFORMATION OF THE RECORDED DATA WITHIN PREOP MANAGER DID NOT TRANSFER TO THE MOST RECENT CASE RECORD WITHIN OPERATION ROOM MANAGER. A MEDICATION WAS ADMINISTERED TO A PATIENT THAT WAS ALLERGIC TO ACETAMETOPHIN AND THE PATIENT EXPERIENCED AN ALLERGIC REACTION OF ITCHING. THIS ISSUE OCCURS UNDER UNIQUE CIRCUMSTANCES WHEN A PATIENT HAS HAD A PRIOR OPERATION AND, UPON A SUBSEQUENT OPERATION, REPORTS NEW DATA THE DAY OF SURGERY THAT WAS NOT REPORTED IN THE PREOPERATIVE ASSESSMENT. THE DATA IS MANUALLY RECORDED IN THE PREOP MANAGER APPLICATION NOT THE OPERATION ROOM MANAGER APPLICATION AND THE DATA IS NOT AUTOMATICALLY RECEIVED FROM A HOSPITAL INFORMATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258616 OPTUM PERIOPERATIVE AND CRITICAL CARE S/W, TRANSM AND STORAGE PATIENT DATA NSX OPTUM CLINICAL SOLUTIONS, INC. 8.3.1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other