BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCKESSON CARDIOLOGY HEMO

    MDR report key: 5890853 · Received August 19, 2016

    Report

    Report Number
    9616760-2016-00002
    Event Type
    Death
    Date Received
    August 19, 2016
    Date of Event
    July 24, 2016
    Report Date
    February 23, 2017
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    DQK
    PMA / PMN Number
    K131497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY ANALYSIS AND ROOT CAUSE DETERMINATION INDICATE THAT THE DEVICE OPERATED AS EXPECTED. THE INVESTIGATION IS ONGOING AND MCKESSON WILL FOLLOW-UP WITH THE FDA WITH ANY NEW INFORMATION LEARNED.

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT OCCURRED DURING AN UPGRADE BEING PERFORMED AT THE CUSTOMER FACILITY ((B)(6) HOSPITAL), FOR TWO MCKESSON CARDIOLOGY HEMO SYSTEMS INSTALLED IN CATH LABS 1 AND 2. IN ORDER TO ENSURE CONTINUED AVAILABILITY OF ONE OF THE CATH LABS DURING THE UPGRADE, MCKESSON INSTALLATION PERSONNEL IMPLEMENTED A PHASED APPROACH TO THE UPGRADE. THIS IS A STANDARD UPGRADE PROCESS, AND IS PERFORMED WITH THE PRIOR AGREEMENT OF CUSTOMERS AND THEIR STAFF. IN ORDER TO COMPLETE A PHASED UPGRADE, ANY WORKSTATIONS THAT WILL REMAIN IN USE ARE PLACED IN "STANDALONE MODE", AND ARE MANUALLY DISCONNECTED FROM THE NETWORK TO ENABLE CONTINUED USE OF THE APPLICATION DURING THE UPGRADE. THE SYSTEM IS DESIGNED TO OPERATE IN "STANDALONE MODE", AND ENABLES WORKSTATIONS TO BE USED WHEN OTHER SYSTEM COMPONENTS, SUCH AS THE DATABASE OR APPLICATION SERVER, ARE NOT CONNECTED DUE TO UNFORESEEN PROBLEMS OCCURRING IN THE ENVIRONMENT (SUCH AS A NETWORK OUTAGE) OR DURING AN UPGRADE. AT THE TIME OF THE INCIDENT ON (B)(6) 2016: CATH LAB 1 HAD BEEN UPGRADED DURING THE INITIAL PHASE OF THE UPGRADE, AND HAD NOT BEEN AUTHORIZED FOR CLINICAL USE AS FINAL TESTING BY THE INSTALLATION TEAM HAD NOT BEEN COMPLETED. CATH LAB 2 HAD NOT YET BEEN UPGRADED, AND THE WORKSTATION HAD BEEN PLACED IN "STANDALONE MODE", AS DESCRIBED ABOVE. MCKESSON'S INSTALLATION TEAM HAD COMPLETED TESTING TO ENSURE THE WORKSTATION IN CATH LAB 2 WAS OPERATIONAL AND AVAILABLE FOR USE IN "STANDALONE MODE". MCKESSON'S INSTALLATION TEAM MONITORED THE WORKSTATION IN CATH LAB 2 THROUGHOUT THE DAY ON (B)(6) 2016, AND CONFIRMED THE WORKSTATION WAS OPERATING AS INTENDED. BASED ON AN ANALYSIS OF THE APPLICATION LOG FILES, A PROCEDURE WAS SUCCESSFULLY PERFORMED USING THE WORKSTATION, AND SIGNED OFF IN THE SYSTEM AT 23:41. AT 23:42, THE USER LOGGED OUT OF THE SYSTEM, AND MANUALLY REBOOTED THE WORKSTATION. ON JULY 24, 2016 AT 5:25 AM, MCKESSON'S SUPPORT DEPARTMENT WERE CONTACTED BY THE CUSTOMER AS THEY WERE UNABLE TO LOG IN TO THE WORKSTATION IN CATH LAB 2. AS THE WORKSTATION HAD BEEN PLACED IN "STANDALONE MODE", MCKESSON'S SUPPORT PERSONNEL WERE UNABLE TO DIRECTLY ACCESS THE WORKSTATION TO TROUBLESHOOT THE ISSUE. A DECISION WAS MADE BY STAFF AT THE CUSTOMER FACILITY TO TRANSFER THE PATIENT BY AMBULANCE TO AN ALTERNATE FACILITY FOR TREATMENT. BASED ON INFORMATION PROVIDED TO MCKESSON THE PATIENT APPEARED TO BE STABLE AT THIS TIME. MCKESSON WERE LATER INFORMED THAT THE PATIENT HAD DIED FOLLOWING A PROCEDURE PERFORMED AT THE ALTERNATE FACILITY ((B)(6)). AFTER A THOROUGH INVESTIGATION AND REVIEW OF APPLICATION LOG FILES, MCKESSON HAVE DETERMINED THAT THE IT CONFIGURATION SETTINGS FOR USER AUTHENTICATION HAD BEEN MODIFIED FROM THE REQUIRED SETTINGS ESTABLISHED AT THE TIME THE WORKSTATION WAS ORIGINALLY INSTALLED IN 2011. THE MODIFIED SETTINGS RELIED UPON THE WORKSTATION BEING CONNECTED TO THE HOSPITAL'S IT NETWORK IN ORDER TO AUTHENTICATE THE USER'S LOGIN CREDENTIALS (USER-NAME AND PASSWORD), AND INCLUDED A SETTING TO "LOCK" THE WORKSTATION WHEN A THRESHOLD OF UNSUCCESSFUL LOGIN ATTEMPTS HAD BEEN EXCEEDED. AS THE WORKSTATION HAD BEEN PUT INTO STANDALONE MODE DUE TO THE UPGRADE AND THE EXPECTED AUTHENTICATION SETTINGS HAD BEEN INCORRECTLY MODIFIED, THE USER'S PASSWORD COULD NOT BE AUTHENTICATED. REPEATED ATTEMPTS BY THE USER TO LOGIN SUBSEQUENTLY RESULTED IN THE MAXIMUM NUMBER OF LOGIN ATTEMPTS BEING EXCEEDED. AS A RESULT, THE WORKSTATION COULD NOT BE IMMEDIATELY ACCESSED. MCKESSON'S INSTALLATION TEAM SUBSEQUENTLY COMPLETED THE UPGRADE OF THE CUSTOMER'S SYSTEM AND RESET THE WORKSTATION TO THE CORRECT CONFIGURATION. MCKESSON HAVE INVESTIGATED INSTALLATIONS OF THE SYSTEM AT OTHER CUSTOMER FACILITIES, AND HAVE CONFIRMED THAT THE CONFIGURATION SETTINGS ARE CORRECT TO ENABLE THE SYSTEM TO OPERATE IN STANDALONE MODE. FROM THE INFORMATION AVAILABLE, THE USER AUTHENTICATION SETTINGS APPEAR TO HAVE BEEN MODIFIED SINCE THE INITIAL SYSTEM INSTALLATION IN 2011. THE CUSTOMER HAS BEEN INFORMED OF THIS ISSUE, AND THE SYSTEM HAS BEEN FUNCTIONING NORMALLY SINCE COMPLETION OF THE UPGRADE. BASED ON THE RESULTS OF THE INVESTIGATION, MCKESSON HAVE FOUND NO EVIDENCE OF A MALFUNCTION WITH THE SYSTEM, AND NO CORRECTIVE ACTION IS PLANNED AT THIS TIME. ACCORDING TO THE INVESTIGATION RESULTS OF THE CUSTOMER, THE PATIENT CAUSE OF DEATH WAS DUE TO COMPLICATIONS FOLLOWING THE MEDICAL PROCEDURE AT ANOTHER HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A USER CONTACTED MCKESSON'S SUPPORT DEPARTMENT AS THEY WERE UNABLE TO LOG INTO THE MCKESSON CARDIOLOGY HEMO WORKSTATION. MCKESSON'S SUPPORT DEPARTMENT WAS UNABLE TO IMMEDIATELY RESOLVE THE ISSUE, AS THE WORKSTATION COULD NOT BE ACCESSED REMOTELY ON THE NETWORK. THE STAFF TREATING THE PATIENT MADE A DECISION TO TRANSFER THE PATIENT TO ANOTHER FACILITY FOR TREATMENT. MCKESSON WAS INFORMED ON AUGUST 1, 2016 THAT THE PATIENT LATER EXPIRED FOLLOWING A PROCEDURE ON (B)(6) 2016 AT THE ALTERNATE FACILITY.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A USER CONTACTED MCKESSON'S SUPPORT DEPARTMENT AS THEY WERE UNABLE TO LOG INTO THE MCKESSON CARDIOLOGY HEMO WORKSTATION. MCKESSON'S SUPPORT DEPARTMENT WAS UNABLE TO IMMEDIATELY RESOLVE THE ISSUE, AS THE WORKSTATION COULD NOT BE ACCESSED REMOTELY ON THE NETWORK. THE STAFF TREATING THE PATIENT MADE A DECISION TO TRANSFER THE PATIENT TO ANOTHER FACILITY FOR TREATMENT. MCKESSON WAS INFORMED ON AUGUST 1, 2016 THAT THE PATIENT LATER EXPIRED FOLLOWING A PROCEDURE ON (B)(6) 2016 AT THE ALTERNATE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543443 MCKESSON CARDIOLOGY HEMO MCKESSON CARDIOLOGY HEMO DQK MCKESSON ISRAEL LTD. 12.2 HF2

    Patients

    Seq Age Sex Outcome Treatment
    1 Death