BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON

    MDR report key: 2507485 · Received March 13, 2012

    Report

    Report Number
    1225058-2012-00003
    Event Type
    Other
    Date Received
    March 13, 2012
    Date of Event
    February 14, 2012
    Report Date
    March 13, 2012
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LMB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIA PURGE DAEMON (MPD) HAS BEEN DEACTIVATED AT THE SITE AND WILL BE REPLACED BY IMPAX CV CARDIO PURGE SERVICE - WHICH WILL DIFFERENTIATE THE IMAGES DEPENDING ON THEIR TYPE. DICOMSTORE CONFIGURATION HAS BEEN MODIFIED AT THE SITE TO ENSURE THAT THE ORIGINAL DICOM IMAGES AND WEB (JPEG VERSIONS) IMAGES ARE STORED ON DIFFERENT HARD DRIVES. RECOVERY OF IMAGES IS CURRENTLY UNDERWAY BY AGFA ENGINEERS BY USING TOOLS ALLOWING IDENTIFYING DELETED FILES ON HARD DRIVES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ROOT CAUSE OF THE DICOMSTORE MISCONFIGURATION IS DETERMINED AND THE ASSESSMENT FOR RECOVERING IMAGES IS COMPLETED. THERE WERE NO REPORTS OF PT HARM, BUT THERE WAS A DELAY IN DIAGNOSIS AND SCHEDULING SURGERY AS A RESULT OF THE BELOW DESCRIBED EVENT AND A RETAKE WAS REQUIRED.

    Description of Event or Problem · 1

    THERE WERE NO REPORTS OF PT HARM, BUT THERE WAS A DELAY IN DIAGNOSIS AND SCHEDULING SURGERY AS A RESULT OF THE BELOW DESCRIBED EVENT. A RETAKE WAS REQUIRED. A DOCTOR AT THE SITE WAS UNABLE TO DISPLAY A PT'S PREVIOUS CARDIAC CATHETERIZATION STUDY FROM (B)(6) 2010. THE IMAGES APPEARED LOST. AGFA'S INVESTIGATION REVEALED THAT THE SITE HAD TWO SANS (STORAGE AREA NETWORK) USED TO STORE IMAGE DATA ON BOTH SANS AT THE SAME TIME AND ONE RIMAGE CD BURNER USED TO ARCHIVE IMAGES ON DVDS. THE IMAGES WERE NOT ARCHIVED FOR LONG TERM ON CDS AS THE RIMAGE CD BURNER NEEDS SITE'S ADMINISTRATOR TO MANUALLY FEED CDS TO THE BURNER AND THIS WAS NOT DONE BY THE SITE. SINCE THE IMAGES WERE NOT ARCHIVED, THE SANS BECAME FULL. THE CONFIGURATION OF THE SYSTEM HAD BEEN MODIFIED TO USE THE 2ND SAN FOR ADDITIONAL STORAGE, BUT THIS WAS NOT A SUPPORTED CONFIGURATION. DICOMSTORE CONFIGURATION WAS ALSO NOT ADEQUATE AS ALL DIFFERENT TYPES OF IMAGES (ONLINE/WEB IMAGES) WERE STORED IN THE SAME FOLDERS. WHEN THE TWO SANS FOLDERS BECAME FULL, TO GAIN STORAGE SPACE, MEDIA PURGE DAEMON (MPD) AUTOMATICALLY STARTED TO DELETE THE OLDEST WEB IMAGES. HOWEVER, MPD DID NOT RECOGNIZE THAT SOME OF THE IMAGES STORED IN THE SAME FOLDER AS THE WEB IMAGES WERE ACTUALLY ORIGINAL DICOM IMAGES AND IT DELETED ALL FILES CONTAINED IN THESE FOLDERS. DUE TO THE MISCONFIGURATION, THESE DELETED IMAGES WERE NOT THE OLDEST ONES; THE AFFECTED IMAGES WERE ACQUIRED BETWEEN LATE 2010 AND 2011. OLDER IMAGES WERE NOT IMPACTED. AGFA IS CURRENTLY DETERMINING ROOT CAUSE OF THE MISCONFIGURATION. (MEDIA PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT. MPD ALLOWS THE SYSTEM TO CONTINUOUSLY RECEIVE THE RECENTLY ACQUIRED IMAGES FROM THIRD PARTIES MODALITIES. THIS TOOL WAS DISCONTINUED AND REPLACED BY CARDIO PURGE SERVICE (CPS) IN JUNE 2008.) THE CUSTOMER SITE WAS STILL USING MPD AT THE TIME OF THIS EVENT. MPD HAS SINCE BEEN DEACTIVATED AT THE SITE AND WILL BE REPLACED BY IMPAX CV CARDIO PURGE SERVICE - WHICH WILL DIFFERENTIATE THE IMAGES DEPENDING ON THEIR TYPE. DICOMSTORE CONFIGURATION HAS BEEN MODIFIED AT THE SITE TO ENSURE THAT THE ORIGINAL DICOM IMAGES AND WEB (JPEG VERSIONS) IMAGES ARE STORED ON DIFFERENT HARD DRIVES. RECOVERY OF IMAGES IS UNDERWAY BY AGFA ENGINEERS BY USING TOOLS ALLOWING IDENTIFYING DELETED FILES ON HARD DRIVES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ROOT CAUSE AND THE ASSESSMENT FOR RECOVERING IMAGES IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON MEDICAL IMAGE STORAGE DEVICE LMB AGFA HEALTHCARE CORP. ALL VERSIONS NA

    Patients

    Seq Age Sex Outcome Treatment
    1