BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWER PROCESSOR

    MDR report key: 1124563 · Received August 18, 2008

    Report

    Report Number
    2050012-2008-00041
    Event Type
    Death
    Date Received
    August 18, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    CLASS I
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE FROM THE EMERGENCY DEPARTMENT WAS LOGGED INTO THE LIS AT 9:26 AM AND LOADED ONTO THE POWER PROCESSOR AT 9:33 AM. THE LAB STATES THAT THEY CHECK THE PENDING SAMPLES ON THE LIS SCREEN HOURLY, AND AT 10:39 THEY NOTICED THAT NONE OF THE TESTS FOR THIS SAMPLE HAD BEEN RUN. THE LAB TECHNICIAN RETRIEVED THE SAMPLE FROM THE POWER PROCESSOR STOCKYARD AND NOTICED THAT IT WAS HEMOLYZED AND AT 10:39 BEGAN APPROPRIATE MEASURES FOR RECOLLECTION. THE LABORATORY STATED THAT THEY WOULD HAVE BEEN ABLE TO RUN CREATININE ON THE HEMOLYZED SAMPLE HAD THEY KNOWN THAT THE ER WAS WAITING FOR THAT SPECIFIC TEST. THE PATIENT WAS REDRAWN; THE REDRAW WAS RECEIVED IN THE LAB AT 10:51 AM. THE CMP WAS REPEATED AND THE RESULTS WERE REPORTED AT 11:15 AM. BCI TECH SUPPORT HAS CONFIRMED THAT THE TOTAL TIME FROM THE FIRST SAMPLE BEING PUT ON THE SYSTEM TO THE RESULTS BEING REPORTED AS SLIGHTLY LESS THAN 2 HOURS. HOWEVER, THEY FOUND NO EVIDENCE OF THE FIRST SAMPLE BEING ROUTED TO EITHER DXC. BCI FSE (FIELD SERVICE ENGINEER) FOUND NO HARDWARE ISSUES WITH THE POWER PROCESSOR OR EITHER DXC. THE FSE ALSO REPORTED THAT THE BARCODE SPINNERS ON THE CONNECTION UNIT WERE FUNCTIONING PROPERLY AND THE TUBE BARCODE VISUALLY LOOKED FINE. THE LABORATORY INFORMED THE FSE THAT BOTH CMP AND BMP (BASIC METABOLIC PANEL - WHICH IS A SUBSET OF THE CMP) WERE ORDERED. BCI TECH SUPPORT HAS INDICATED THAT THIS WOULD NOT CAUSE A PROBLEM WITH THE SAMPLE REPROGRAMMING AS THE DUPLICATE TESTS WOULD BE IGNORED BY THE DATALINK SYSTEM. BCI TECHNICAL SUPPORT HAS CONFIRMED THAT A BARCODE READ ERROR AT THE DXC CONNECTOR WOULD HAVE CAUSED A VISUAL ALARM AT THE CONNECTOR. AT BAR CODE READ ERROR THE DXC WOULD CAUSE AN AUDIBLE ALARM TO SOUND (UNLESS IT HAD BEEN TURNED OFF) AND A VISUAL ERROR MESSAGE AT THE DXC. THE DXC WILL NOT CONTINUE TO PROCESS THE SAMPLE UNTIL THE ERROR MESSAGE IS ACKNOWLEDGED AND THE ERROR IS CORRECTED. IN ADDITION, THE LABORATORY RUNS SERUM INDICES ON THE DXC, WHICH WOULD HAVE FLAGGED THE HEMOLYZED SAMPLE HAD IT RUN. BCI TECHNICAL SUPPORT CONFIRMED THAT SERUM INDICES PRINT AS A NOTE ON THE SAMPLE PRINTOUT ALONG WITH THE CHEMISTRY RESULTS FOR THE SAMPLE. THE POWER PROCESSOR EVENT LOG WHICH WAS VIEWABLE IN 2008 WAS NOT AVAILABLE ABOUT TWO DAYS LATER, BECAUSE IT HAD ALREADY BEEN OVERWRITTEN. THE LAB IS NOT AWARE OF ANY OTHER SAMPLE TUBES BEING DELAYED THAT DAY. THERE HAVE BEEN NO KNOWN RELATED ISSUES WITH THE POWER PROCESSOR OR DXC SYSTEMS RELATED TO THIS INCIDENT. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    ON AUGUST 13, 2008, A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THEY WERE INVESTIGATING A FAILURE TO ANALYZE A SAMPLE IN 2008. THEY REPORTED THAT THEIR EMERGENCY ROOM BELIEVED THAT DELAY IN RESULTS CAUSED A DELAY IN DETERMINING THAT THE PATIENT NEEDED ANOTHER DIFFERENT TEST, AND IF THE OTHER TEST HAD BEEN DONE SOONER THEY MAY HAVE BEEN ABLE TO SAVE THE PATIENT. THE LABORATORY IS CONFIGURED WITH A POWER PROCESSOR SYSTEM WITH 2 UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER CONNECTIONS, 1 UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM CONNECTION, A 3060-TUBE STOCKYARD (CONTROLLED TEMPERATURE STORAGE), A HEMATOLOGY OUTLET, A RECAPPER AND A SECONDARY DECAPPER. THESE ARE CONTROLLED AND CONNECTED TO THE LIS (LABORATORY INFORMATION SYSTEM) WITH DATALINK SOFTWARE. ON THE EVENT DATE, THE CUSTOMER'S EMERGENCY ROOM SUBMITTED A PATIENT SAMPLE WITH A REQUEST TO PERFORM A COMPREHENSIVE METABOLIC PANEL (CMP) OF TESTS. THE LABORATORY LATER LEARNED THAT THE EMERGENCY ROOM WAS SPECIFICALLY WAITING FOR THE CREATININE RESULTS, WHICH THE EMERGENCY ROOM BELIEVED WERE NEEDED PRIOR TO IMAGING STUDIES WITH IV CONTRAST TO CHECK FOR AORTIC DISSECTION. THE LABORATORY PROGRAMMED THE POWER PROCESSOR TO SORT THE SAMPLE TO THE DXC ANALYZER CONNECTION #1; IT THEN BYPASSED DXC CONNECTION #2 AND WAS SORTED TO THE STOCKYARD IN A PENDING STATUS. THE POWER PROCESSOR IS SET BY DEFAULT FOR A 30-MINUTE TIMEOUT AT THE STOCKYARD, MEANING SAMPLES THAT HAVE NOT BEEN PROCESSED BY AN ANALYZER WITHIN 30 MINUTES ARE SENT TO THE "PENDING" RACK, INDICATING THEY REQUIRE ADDITIONAL HANDLING BY THE LABORATORY TECHNICIAN. (ATTACHED IFU OUTLINES THE POWER PROCESSOR OVERVIEW FLOW). THE LABORATORY REPORTS THAT THE DXC WAS NOT IN MANUAL MODE AT THE TIME, AND THAT ALL OF THE CHEMISTRIES WERE AVAILABLE ON BOTH CONNECTED DXC SYSTEMS. PER OPERATOR, THEY NOTICED THE SAMPLE ON THE LIS PENDING LIST (WITH NO RESULTS FOR ANY TEST) SOME 45 MINUTES LATER AFTER THE SAMPLE WAS LOADED ONTO THE POWER PROCESSOR AND RETRIEVED IT FROM THE STOCKYARD. THE SAMPLE WAS NOTED TO BE HEMOLYZED. A REDRAWN SPECIMEN WAS OBTAINED AND RESULTS REPORTED 1 HOUR 45 MINUTES AFTER THE FIRST SAMPLE WAS LOADED ONTO THE POWER PROCESSOR. THE PATIENT EXPIRED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROCESSOR CLINICAL AUTOMATION JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death