BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHANGE HEALTHCARE CARDIOLOGY HEMO

    MDR report key: 12018365 · Received June 17, 2021

    Report

    Report Number
    9616760-2021-00001
    Event Type
    Death
    Date Received
    June 17, 2021
    Date of Event
    May 20, 2021
    Report Date
    November 24, 2021
    Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY
    Product Code
    DQK
    UDI-DI
    17540262100037
    PMA / PMN Number
    K131497
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FINAL INVESTIGATION REVEALED THAT THE REPORTED MALFUNCTION, RELATED TO A PROBLEMATIC NIC CONNECTION, WAS DUE TO A FAULTY CABLE, PREVIOUSLY REPORTED AS AN INCOMPLETE OS BOOT OF THE RT MONITOR. SUPPORT'S INVESTIGATION REVEALED THAT THE BOOT WAS NOT SUCCESSFUL AND RESULTED IN COMMUNICATION ISSUES BETWEEN THE INFOSYSTEM AND RT MONITOR. ONCE SUPPORT ASSISTED WITH PERFORMING A CLEAN REBOOT OF THE RT MONITOR AND RECONFIGURATION OF THE NIC CARD, THE CONNECTION WAS RESTORED SUCCESSFULLY AND THERE WERE NO FURTHER ISSUES ENCOUNTERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN EMERGENCY STEMI PROCEDURE IN THE CATHERIZATION LAB INVOLVING A PATIENT IN CRITICAL STATE, THE CONTROL PANEL ON THE INFOSYSTEM'S APPLICATION WAS GREYED OUT AND AS A RESULT, THE USERS WERE NOT ABLE TO CONTROL THE RT MONITOR OR TAKE HEMODYNAMIC SAMPLES USING THE INFOSYSTEM. THE USER DID NOT USE THE RT MONITOR KEYPAD WHICH ALLOWS CONTROL OVER THE RT MONITOR DISPLAY WHEN THE CONTROL PANEL OF THE INFOSYSTEM IS GREYED OUT, AS INDICATED IN THE CHANGE HEALTHCARE HEMO USER GUIDE. THE PATIENT WAS THEN MOVED TO A DIFFERENT LAB WHERE THE PROCEDURE WAS COMPLETED. SUBSEQUENT TO THE PROCEDURE THE PATIENT EXPIRED. DURING THE PROCEDURE THE PATIENT WAS ALSO CONNECTED TO ANAESTHESIA EQUIPMENT WHICH ALLOWED AUXILIARY MONITORING OF THE PATIENT'S VITALS SIGNS.

    Additional Manufacturer Narrative · 1

    THE REPORTING FACILITY STATED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT. PRELIMINARY INVESTIGATION REVEALED THAT THE REPORTED MALFUNCTION WAS ASSOCIATED WITH THE NETWORK CABLING OR ASSOCIATED COMPONENTS. THE REPORTING FACILITY CONFIRMED THAT THE CONNECTION BETWEEN THE RT MONITOR AND THE INFOSYSTEM WAS RESTORED SUCCESSFULLY AFTER REPLACEMENT OF THE NETWORK HARDWARE COMPONENT. FURTHER INVESTIGATION IS STILL IN PROCESS TO DETERMINE THE ROOT CAUSE OF THE EVENT. CHANGE HEALTHCARE WILL PROVIDE A FOLLOW UP REPORT TO THE AGENCY ONCE ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMERGENCY STEMI PROCEDURE IN THE CATHERIZATION LAB INVOLVING A PATIENT IN CRITICAL STATE, THE CONTROL PANEL ON THE INFOSYSTEM'S APPLICATION WAS GREYED OUT AND AS A RESULT, THE USERS WERE NOT ABLE TO CONTROL THE RT MONITOR OR TAKE HEMODYNAMIC SAMPLES USING THE INFOSYSTEM. THE USER DID NOT USE THE RT MONITOR KEYPAD WHICH ALLOWS CONTROL OVER THE RT MONITOR DISPLAY WHEN THE CONTROL PANEL OF THE INFOSYSTEM IS GREYED OUT, AS INDICATED IN THE CHANGE HEALTHCARE HEMO USER GUIDE. THE PATIENT WAS THEN MOVED TO A DIFFERENT LAB WHERE THE PROCEDURE WAS COMPLETED. SUBSEQUENT TO THE PROCEDURE THE PATIENT EXPIRED. DURING THE PROCEDURE THE PATIENT WAS ALSO CONNECTED TO ANAESTHESIA EQUIPMENT WHICH ALLOWED AUXILIARY MONITORING OF THE PATIENT'S VITALS SIGNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913396 CHANGE HEALTHCARE CARDIOLOGY HEMO CHANGE HEALTHCARE CARDIOLOGY HEMO DQK CHANGE HEALTHCARE CANADA COMPANY 14.2 17540262100037

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death