BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPAX DB SERVER 5.2

    MDR report key: 2982889 · Received February 28, 2013

    Report

    Report Number
    2249582-2013-00001
    Event Type
    Death
    Date Received
    February 28, 2013
    Date of Event
    January 16, 2013
    Report Date
    October 11, 2013
    Manufacturer
    AGFA HEALTHCARE CORPORATION
    Product Code
    LLZ
    PMA / PMN Number
    K111945
    Removal / Correction Number
    TBD BY FDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURER DATE HAS BEEN CORRECTED FROM 06/01/2011 TO 12/17/2004.

    Description of Event or Problem · 1

    (B)(4). THE SLOW PERFORMANCE / SERVER DOWNTIME EXPERIENCED AT THE SITE HAVE BEEN DETERMINED TO BE RELATED TO MULTIPLE ROOT CAUSES, LISTED BELOW. THE SITE IS RUNNING A TIVOLI BACKUP DURING WORKING HOURS THAT IS HEAVILY IMPACTING CPU LOADS. IT WAS RECOMMENDED THAT THIS BACKUP BE RESCHEDULED FOR OFF PEAK HOURS. THE ORACLE VERSION RUNNING AT THE SITE (10.1.0.4.0) HAS A KNOWN DEFECT. THE ISSUE WAS RESOLVED IN ORACLE 10.2.0.2 AND THE SITE HAS BEEN ADVISED TO UPGRADE TO THIS VERSION OR HIGHER. AS RECOMMENDED BY ORACLE THE SITE IS TO INSTALL ORACLE PATCH 3650599. CHANGE THE FILE SYSTEM LAYOUT OF ¿/DBASE¿ AND ¿/DBASE1¿ SO THAT IT WILL MATCH AGFA¿S REQUIREMENTS FOR IMPAX-DATABASES AND BEST PRACTICE GUIDELINES. MIGRATE TO LMT (LOCALLY-MANAGED-TABLE SPACES). THE SITE HAS A TEMP-DATA FILE THAT IS 30GB BIG. THIS IS NOT RECOMMENDED AND CANNOT BE CREATED WITH THE TOOLS THAT ARE SUGGESTED TO BE USED BY AGFA. THIS ISSUE WILL BE REVIEWED AS IT VIOLATES AGFA'S BEST PRACTICE. UPGRADE TO IMPAX 6.5, SCHEDULED IN SEPT 2013. ON SEPTEMBER 19, 2013, AGFA HEALTHCARE VOLUNTARY REPORTED THIS ISSUE TO THE FDA & HEALTH (B)(4). CORRECTIONS RECOMMENDED TO SITE: RESCHEDULE TIVOLI BACKUP, UPGRADE ORACLE, CHANGE FILE SYSTEM LAYOUT TO MATCH AGFA'S REQUIREMENTS, MIGRATE TO LMT, & REVIEW SITES' TEMP-DATA FILE. AGFA AND (B)(6) HOSPITAL ARE IN PREPARATION FOR THE UPGRADE TO IMPAX 6.5 IN OCTOBER 2013. ALL OTHER DOCUMENTATION WILL BE REPORTED TO THE FDA VIA (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, A (B)(6) FEMALE PATIENT (IDENTIFICATION WITHHELD) WAS TRANSFERRED FROM (B)(6) HOSPITAL TO (B)(6) HOSPITAL (BOTH IN (B)(6)) FOR FURTHER TREATMENT OF AN UNSPECIFIED CARDIAC/CHEST CONDITION. AT THE TIME OF TRANSFER, THE PATIENT'S COMPUTED TOMOGRAPHY (CT) STUDY OF THE CHEST ACQUIRED AT (B)(6) WAS ELECTRONICALLY TRANSMITTED TO (B)(6). AT THE TIME OF THE STUDY TRANSMISSION, (B)(6) WAS EXPERIENCING AN EPISODE OF DOWNTIME WHICH CAUSED THE STUDY TRANSMISSION TO BE DELAYED. WHEN THE (B)(6) STAFF DISCOVERED THAT THE STUDY IN QUESTION COULD NOT BE ACCESSED IN IMPAX, THEY DECIDED TO PERFORM ANOTHER EXAM ON THE PATIENT, BUT UNFORTUNATELY THE PATIENT EXPIRED DURING THIS TIME. THE AFFECTED STUDY BECAME AVAILABLE IN IMPAX APPROXIMATELY TWO HOURS FOLLOWING THE PATIENT'S DEMISE AFTER THE EPISODE OF DOWNTIME OCCURRED. PRIOR TO THIS EVENT, (B)(6) HAD CONTACTED AGFA EARLIER ON (B)(6) 2013 TO CHECK THE DOWNTIME ISSUE. AGFA ADDED NEW DATAFILES, RESTARTED (B)(4) AND CONFIRMED IMPAX WAS OPERATIONAL ON (B)(6) 2012, BUT AGAIN THIS WAS BEFORE THE EVENT OCCURRED WITH THE PATIENT. THE DATE AGFA BECAME AWARE OF THE EVENT WAS NOT UNTIL (B)(4) 2013, WHEN THE CUSTOMER, (B)(6), CONTACTED AGFA AND TOLD AGFA THEY WERE CONDUCTING AN INTERNAL INVESTIGATION AND REQUESTED ASSISTANCE FROM AGFA TO LOCATE THE SPECIFIC MISSING AUDIT LOGS RELATED TO THE REMOTELY ACQUIRED STUDY THAT WAS DELAYED FROM (B)(6) ON (B)(6) 2013. AN AGFA SERVICE ENGINEER IMMEDIATELY OPENED A PRODUCT COMPLAINT ON (B)(6) 2013 AND ALSO SUCCESSFULLY OBTAINED AND DELIVERED THE REQUESTED LOGS TO THE CUSTOMER. AGFA HAS SINCE MADE MULTIPLE ATTEMPTS TO THE CUSTOMER TO OBTAIN SPECIFIC CLINICAL DETAILS SURROUNDING THE PATIENT DEATH, BUT AT THIS TIME, THE CUSTOMER HAS NOT MADE THESE DETAILS AVAILABLE. THE PRODUCT IMPAX 5.2 WAS END OF LIFE (B)(6) 2008. THE END OF SERVICE LIFE WAS (B)(6) 2010. AGFA AND THE SITE ARE CURRENTLY IN PREPARATION TO UPGRADE THEIR SYSTEM FROM IMPAX 5.2 TO IMPAX 6.5. AT THIS TIME AGFA CONSIDERS ROOT CAUSE TO BE RELATED TO SITE NETWORK ISSUES, 3RD PARTY ISSUES AND THAT THE PRODUCT HAS BEEN END OF LIFE FOR OVER 4 YEARS AND END OF SERVICE LIFE FOR OVER 2 YEARS, REQUIRING SIGNIFICANT MAINTENANCE. IF WE OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER, WE WILL SUBMIT A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86278 IMPAX DB SERVER 5.2 MEDICAL DEVICE DATA SYSTEM LLZ AGFA HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death