BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS LYSE WASH ASSISTANT

    MDR report key: 11739825 · Received April 28, 2021

    Report

    Report Number
    2916837-2021-00209
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 5, 2021
    Report Date
    September 10, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    UDI-DI
    00382903371464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACS LYSE WASH ASSISTANT, PART # 337146 AND SERIAL # (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT OF A CARRYOVER ISSUE. ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 05APR2020 TO DATE 05APR2020. ¿ COMPLAINT TREND: THERE ARE 8 COMPLAINTS RELATED TO THE CARRYOVER ISSUE; DATE RANGE FROM 05APR2020 TO 05APR2021. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 337146 SERIAL # R337146000836, FILE # 337146-337146-R337146000836-105802072-18, WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF THE CARRYOVER ISSUE WAS DUE MATERIAL BUILD UP AND CLOGGING. AFTER MULTIPLE VISITS, THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THAT THE SYSTEM NEEDED HEAVY CLEANING AND MAINTENANCE THE FSE HAD TO OPEN THE WASHING STATION TO DO A THOROUGH CLEANING, CLEAR THE FLUIDIC LINES, AND CLEAR THE ORIFICE OF MATERIAL. ANY BLOCKAGE AND MATERIAL BUILDUP WILL CAUSE THE INSTRUMENT TO NOT RUN AT ITS OPTIMAL PERFORMANCE. USER SHOULD BE PERFORMING PROPER DAILY AND MONTHLY CLEANING PROCEDURES, WHICH CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD FACS¿ LYSE WASH ASSISTANT SYSTEM INSTRUCTIONS FOR USE, #23-11113-01 REV. 1/VERS. A, PAGE 111. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. ALTHOUGH THE UNEXPECTED RESULTS WERE FROM PATIENT SAMPLE, NO PATIENT WAS TREATED NOR HARMED FROM INCORRECT RESULTS. THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSIS DECISION AND WAS REPORTED TO BD AS NOT EXPECTED. THE CURRENT LWA CARRYOVER PROTOCOL (23-23520-00 VERSION A, REVISION 01) WAS LAST UPDATED IN NOVEMBER 2020, AND IT OUTLINES THE PROPER METHOD IN PREPARING THE SAMPLES AND RUNNING ANALYSES ON THOSE SAMPLES. AFTER A THOROUGH CLEANING OF THE LWA, THE INSTRUMENT IS RUNNING AS EXPECTED. THE SAFETY RISK FOR CARRYOVER BETWEEN SAMPLES IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 01868838, 01897872, 01905755, 01907410, CASE # 01311919 INSTALL DATE: 08NOV2018 DEFECTIVE PART NUMBER: N/A WORK ORDER NOTES: WO #01868838 O SUBJECT / REPORTED: CARRYOVER O PROBLEM DESCRIPTION: THEY OBSERVED PATIENT SAMPLE RUSE TO HEALTHY WHEN USING LWA ON THURSDAY (THERE WERE ONLY THESE SAMPLES IN LWA). ON SATURDAY, NARA DECIDED TO TEST AGAIN, SIMULATING THE SAME SITUATION, BUT DID NOT OBSERVE CARRYOVER; HOWEVER, THE SAMPLE WAS ALREADY OLD AND DEGRADED, WITH A BIAS. I RECOMMENDED PERFORMING THE CARRYOVER TEST USING WATER PIPES BETWEEN THE SAMPLES AND ACQUIRING THE WATER PIPES IN THE CYTOMETER. INSTRUCTIONS WILL BE EMAILED. O WORK PERFORMED: THE EQUIPMENT WAS OPENED AND THE WASHING SYSTEM DISASSEMBLED. A CLEANING WAS PERFORMED ON THE INTERNAL MECHANISMS OF THE WASHING PROBE. THERE WAS A CRUST OF BIOLOGICAL MATERIAL, WHICH MAY BE RESPONSIBLE FOR THE REPORTED PROBLEM. THE WASHING AND RINSING STATIONS WERE ALSO CLEANED. TESTS WERE CARRIED OUT SIMULATING THE CUSTOMER'S ROUTINE, WITH TUBES CONTAINING ARTIFICIAL COLORING. NO VISUAL SIGNS OF DRAG WERE OBSERVED. THE CLIENT WAS INSTRUCTED TO REPEAT THE TEST PROTOCOL PASSED BY THE ADVISORY AND SEND TO THE ASSESSOR BRUNA TO DO THE ANALYSIS AND COMPARE WITH THE OLD RESULTS O CAUSE: CONTAMINATION IN THE WASHING SYSTEM. O SOLUTION: EQUIPMENT RELEASED FOR TESTING AND WILL BE RELEASED AFTER ANALYSIS OF THE RESULTS BY THE ADVISORY. WO #01897872: O SUBJECT / REPORTED: CARRYOVER O PROBLEM DESCRIPTION: THEY OBSERVED PATIENT SAMPLE RUSE TO HEALTHY WHEN USING LWA ON THURSDAY (THERE WERE ONLY THESE SAMPLES IN LWA). ON SATURDAY, NARA DECIDED TO TEST AGAIN, SIMULATING THE SAME SITUATION, BUT DID NOT OBSERVE CARRYOVER; HOWEVER, THE SAMPLE WAS ALREADY OLD AND DEGRADED, WITH A BIAS. I RECOMMENDED PERFORMING THE CARRYOVER TEST USING WATER PIPES BETWEEN THE SAMPLES AND ACQUIRING THE WATER PIPES IN THE CYTOMETER. INSTRUCTIONS WILL BE EMAILED. O WORK PERFORMED: DURING SERVICE, THE EQUIPMENT WAS DISASSEMBLED FOR A GENERAL OVERHAUL. THE WASHING CELL HEAD HAS BEEN DISASSEMBLED AND THE SEALING RINGS AND SEALS OF THE WASHING SYSTEM HAVE BEEN REPLACED. BOTH THE INNER AND OUTER TUBES OF THE WASH PROBE HAVE ALSO BEEN REPLACED. THE BAL SEAL BLOCK OF THE WASHING STATION WAS ALSO REPLACED. AFTER THIS INTERVENTION, THE QUALIFICATION PROCEDURE WAS CARRIED OUT. ALL TESTS, CHECKS AND ADJUSTMENTS WERE CARRIED OUT AND THE VALUES RECORDED IN THE QUALIFICATION WORKSHEET. FOLLOWING THE VERIFICATION PROTOCOL, IN THE RINSE PUMP TEST I OBSERVED AN ABNORMAL PERFORMANCE, WITH INTERMITTENT FAILURES, WHICH WOULD RESULT IN THE ABSENCE OF PROPER CLEANING OF THE BAL SEAL BETWEEN TUBES. THE REASON WAS THE FLOW RESTRICTOR ON THAT LINE. THE PART IN QUESTION WAS REPLACED, AND THE RINSE PUMP TESTS PERFORMED MUCH BETTER, AS IT SHOULD IN NORMAL OPERATION. FOLLOWING THE SERVICE THE NEXT DAY, A DRAG TEST WAS PERFORMED USING THE BLUE BEADS. 5 TUBES WITH BLUE BEADS AND 6 TUBES WITH WATER ALONE WERE PREPARED TO BE PROCESSED IN THE LWA. AFTER WASHING THESE TUBES IN THE LWA, THE SAMPLES WERE ACQUIRED IN AN EXPERIMENT CREATED SPECIFICALLY FOR THIS PURPOSE IN FACSCANTO II. THE RESULTS OF THIS ACQUISITION DID NOT INDICATE ANY INDICATION OF DRAGGING FROM THE BLUE BEADS TO THE TUBES WITH WATER. THUS, THE CLIENT WAS INSTRUCTED TO REDO THE DRAG TEST PROCEDURE WITH BIOLOGICAL MATERIAL, AS INSTRUCTED BY THE SCIENTIFIC ADVISORY. AFTER ANALYZING THIS TEST, THE EQUIPMENT WILL BE RELEASED FOR USE. O CAUSE: RINSE PUMP FLOW RESTRICTOR SEMI OBSTRUCTED. O SOLUTION: EQUIPMENT RELEASED FOR BIOLOGICAL VALIDATION TESTING. WO #01905755: O SUBJECT / REPORTED: CARRYOVER O PROBLEM DESCRIPTION: THEY OBSERVED PATIENT SAMPLE RUSE TO HEALTHY WHEN USING LWA ON THURSDAY (THERE WERE ONLY THESE SAMPLES IN LWA). ON SATURDAY, NARA DECIDED TO TEST AGAIN, SIMULATING THE SAME SITUATION, BUT DID NOT OBSERVE CARRYOVER; HOWEVER, THE SAMPLE WAS ALREADY OLD AND DEGRADED, WITH A BIAS. I RECOMMENDED PERFORMING THE CARRYOVER TEST USING WATER PIPES BETWEEN THE SAMPLES AND ACQUIRING THE WATER PIPES IN THE CYTOMETER. INSTRUCTIONS WILL BE EMAILED. O WORK PERFORMED: SANTA LUZIA VISIT TO CARRY OUT VERIFICATION OF LWA. WE PERFORMED THE CLIENT'S PERSONALIZED PROTOCOL (WASHING WITH 2 ML + ADDITIONAL 150 ¿L OF PBS) AND THE STANDARD PROTOCOL FROM BD WASH ONLY. WE POSITIONED THE LWA: SAMPLE FOLLOWED BY 2 TUBES OF PBS. AT FACSCANTO, AFTER CLEANING, WE ACQUIRED THE SAMPLE TUBE AND THE PBS TUBE (TUBE SUBSEQUENT TO THE SAMPLE) INTERCALATED WITH FILTERED FACSFLOW. THE SSCXFSC GRAPHS SHOW LOW EVENTS IN THE PBS TUBES, WHICH DID NOT ALTER THE ANALYSIS OR CHARACTERIZED CARRYOVER. THE SAME WAS OBSERVED FOR CD45 LABELING. THE DASA TEAM REPORTED THAT THEY WERE USING 2 ML OF LYSIS SOLUTION IN PREPARING THE SAMPLES. WE RECOMMEND REDUCING THE VOLUME TO 1 ML, AS 2 ML EXCEEDS THE MAXIMUM SAMPLE VOLUME TO BE INSERTED IN THE LWA, WHICH CAN OVERFLOW AT THE TIME OF WASHING AND CAN CAUSE CONTAMINATION AND ACCUMULATION OF RESIDUES IN THE SYSTEM. IN THE TESTS PERFORMED DURING THE VISIT, THE VOLUME OF 1 ML OF LYSIS AND 1 ¿L OF CD45 V500 WAS USED. THE DASA TEAM ALSO INFORMED THAT THEY ARE NOT AWARE OF THE MONTHLY CLEANING (DECONTAMINATE CLEANSE - DECONTAMINATION OF THE SYSTEM). THE PROCEDURES HAVE BEEN DEMONSTRATED AND WE RECOMMEND CARRYING OUT MONTHLY. WE ALSO RECOMMEND ADDING THE DECONTAMINATION OF THE WASHING STATION WEEKLY AND ALSO CLEANING THE RESERVOIRS WITH 1% HYPOCHLORITE AND DISTILLED WATER MONTHLY. O CAUSE: ACCUMULATION OF RESIDUE IN THE SYSTEM AND USE OF A SAMPLE WITH A VOLUME ABOVE THAT RECOMMENDED IN THE MANUAL. O SOLUTION: EQUIPMENT RELEASED FOR USE. WO #01907410: O SUBJECT / REPORTED: CARRYOVER O PROBLEM DESCRIPTION: THEY OBSERVED PATIENT SAMPLE RUSE TO HEALTHY WHEN USING LWA ON THURSDAY (THERE WERE ONLY THESE SAMPLES IN LWA). ON SATURDAY, NARA DECIDED TO TEST AGAIN, SIMULATING THE SAME SITUATION, BUT DID NOT OBSERVE CARRYOVER; HOWEVER, THE SAMPLE WAS ALREADY OLD AND DEGRADED, WITH A BIAS. I RECOMMENDED PERFORMING THE CARRYOVER TEST USING WATER PIPES BETWEEN THE SAMPLES AND ACQUIRING THE WATER PIPES IN THE CYTOMETER. INSTRUCTIONS WILL BE EMAILED. O WORK PERFORMED: A VISIT WAS CARRIED OUT TO VERIFY THE CARRYOVER. GENERAL EQUIPMENT OVERHAUL, QUALIFICATION. TESTS WITH DYES, HYPOCHLORITE 1%, CS&T BEADS (RECORDED IN FACSDIVA OF FACSCANTO II), USING 20 TUBES INTERSPERSED WITH DISTILLED WATER. MONITORING THE TESTS WITH FAS BRUNA WHO WILL DO AN ANALYSIS OF THE RESULTS. ALL ENGINEERING TESTS SHOW THAT THE EQUIPMENT IS NORMAL, WITH NO CONTAMINATION BETWEEN SAMPLES. O CAUSE: NOTHING FOUND. O SOLUTION: INSTRUMENT RELEASED FOR USE. CONFIRMED WITH THE CUSTOMER ABOUT CLEANING PROTOCOLS. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 337146RA, REV. 02/VERS. C, BD FACS¿ LYSE/WASH ASSISTANT RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO O ID: 2.1.1 O HAZARD: CARRYOVER O CAUSE: CLOGGED ORIFICE O HARMFUL EFFECTS: INCORRECT RESULTS, DAMAGED INSTRUMENT O RISK CONTROL: REPLACE ORIFICE AT EACH PM INTERVAL O IMPLEMENTATION VERIFICATION: RELIABILITY TESTING IN SV LAB; PROTOCOL: GPPD0010-03 REV A. O EFFECTIVENESS VERIFICATION: SYSTEM CHARACTERIZATION SUMMARY REPORT LWA CARRYOVER EVALUATION PHASE III VERSION 1.0 10/MAR/2010 O PROBABILITY: 1 O SEVERITY: 3 O RISK INDEX: 3 O RESIDUAL RISK EVALUATION: A O NEW HAZARDS: NONE MITIGATION(S) SUFFICIENT ¿YES ¿NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE WAS DUE TO MATERIAL BUILDUP AND CLOGGING. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE CARRYOVER ISSUE IS DUE TO MATERIAL BUILDUP AND CLOGGING. THE FSE CONFIRMED THE ISSUE AND PREFORMED A CLEANING OF THE WASHING SYSTEM, FLUIDIC LINES, AND ORIFICE OF MATERIAL. AFTER THE CLEANING, THE INSTRUMENT WAS TESTED, AND FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE CARRYOVER ISSUE. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OF "SICK" SAMPLE TO "HEALTHY" ONE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THEY OBSERVED CARRYING A SICK SAMPLE TO A HEALTHY ONE WHEN USING THE LWA ON THURSDAY (THERE WERE ONLY THESE SAMPLES IN THE LWA). ON SATURDAY, DECIDED TO TEST AGAIN, SIMULATING THE SAME SITUATION, BUT DID NOT OBSERVE CARRYOVER; HOWEVER, THE SAMPLE WAS ALREADY OLD AND DEGRADED, WITH A BIAS. I RECOMMENDED CARRYING OUT THE CARRYOVER TEST USING WATER TUBES BETWEEN THE SAMPLES AND PURCHASING THE WATER TUBES ON THE CYTOMETER. CLIENT REQUESTED CARRYOVER PROTOCOL AND CALCULATIONS. WE ARE WAITING FOR IT TO CARRY OUT THE TESTS TO ASSESS WHETHER THE CARRYOVER HAS CEASED TO OCCUR.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD FACS" LYSE WASH ASSISTANT CARRYOVER OF "SICK" SAMPLE TO "HEALTHY" ONE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THEY OBSERVED CARRYING A SICK SAMPLE TO A HEALTHY ONE WHEN USING THE LWA ON THURSDAY (THERE WERE ONLY THESE SAMPLES IN THE LWA). ON SATURDAY, DECIDED TO TEST AGAIN, SIMULATING THE SAME SITUATION, BUT DID NOT OBSERVE CARRYOVER; HOWEVER, THE SAMPLE WAS ALREADY OLD AND DEGRADED, WITH A BIAS. I RECOMMENDED CARRYING OUT THE CARRYOVER TEST USING WATER TUBES BETWEEN THE SAMPLES AND PURCHASING THE WATER TUBES ON THE CYTOMETER. CLIENT REQUESTED CARRYOVER PROTOCOL AND CALCULATIONS. WE ARE WAITING FOR IT TO CARRY OUT THE TESTS TO ASSESS WHETHER THE CARRYOVER HAS CEASED TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634558 BD FACS LYSE WASH ASSISTANT STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 337146 NA 00382903371464

    Patients

    Seq Age Sex Outcome Treatment
    1