BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ACCURI

    MDR report key: 12247841 · Received July 29, 2021

    Report

    Report Number
    2916837-2021-00320
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 2, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD ACCURI C6 PLUS SYSTEM, PART # 660517, SERIAL # (B)(6) . PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING A LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 02JUL2020 TO 02JUL2021. COMPLAINT TREND: THERE ARE 12 COMPLAINTS RELATED TO A LEAKAGE OF WASTE NOT CONTAINED WITHIN THE INSTRUMENT DUE TO BLOCKAGES/CLOGS WITHIN THE FLUIDICS SYSTEM; DATE RANGE FROM 02JUL2020 TO 02JUL2021. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 660517 SERIAL # (B)(6), FILE #(B)(4), 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 BIOHAZARD LEAK WAS DUE TO CLOGS IN THE FLUIDICS TUBING. DIRT, BLOCKAGES, AND CLOGS IN THE FLUIDIC SYSTEM WILL CONTRIBUTE TO FLOW RATE, BACKFLOW ISSUES, ASPIRATION ISSUES AND LEAKAGES. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THE ISSUE AND CLEANED THE BLOCKED PIPES AND JOINTS. WHILE THE DESCRIPTION OF THE ISSUE IN (B)(4) DETAILS A BROKEN RED PIPE, IT IS REFERRING TO THE BLOCKAGE WITHIN THAT WASTE LINE. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO REPLACED PARTS. AFTER THE REPAIR THE INSTRUMENT WAS TESTED AND WAS PERFORMING AS EXPECTED WITH NO FURTHER LEAKS. ALTHOUGH THE LEAKAGE OF BIOHAZARDOUS MATERIAL CAN CAUSE HARM TO THE CUSTOMER FROM EXPOSURE TO SAMPLES AND CHEMICALS, THE CUSTOMER WAS NOT HARMED IN ANY WAY AS THEY HAD NOT COME IN CONTACT WITH THE LEAKAGE. ADDITIONALLY, THE LEAK WAS NOT UNDER PRESSURE AND DID NOT SPRAY, AND THUS DID NOT SIGNIFICANTLY INCREASE THE RISK OF EXPOSURE. THIS INSTRUMENT WAS BEING USED FOR RESEARCH PURPOSES, NOT CLINICAL TREATMENT, AND SO THIS INCIDENT DID NOT AFFECT OR DELAY THE DIAGNOSIS OF A PATIENT. PROPER SCHEDULED CLEANING AND OTHER MAINTENANCE CAN HELP IN REDUCING THE POSSIBILITY OF BLOCKAGES OR CLOGS WITHIN THE FLUIDICS SYSTEM, AND INSTRUCTIONS CAN BE FOUND IN CHAPTER 10 OF THE BD ACCURI¿ C6 PLUS SYSTEM USER¿S GUIDE (#23-18013-01 REV. 1/VERS. A). THE SAFETY RISK IS SEVERE, S4, THOUGH THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4) / (B)(4), CASE # (B)(4). INSTALL DATE: (B)(6) 2019. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES((B)(4)): O SUBJECT / REPORTED: (B)(6) -ACCURI C6 PLUS-INSTRUMENT LEAKAGE. O PROBLEM DESCRIPTION: ACCURI C6 PLUS-THE INSTRUMENT IS LEAKING, THE RED PIPE IS BROKEN AND THE WASTE IS LEAKED. FOR SCIENTIFIC RESEARCH USE, THE QUOTATION HAS BEEN STAMPED AND SENT BACK. FOLLOW-UP CONTACT TEACHER (B)(6) : (B)(6). O WORK PERFORMED: THROUGH TELEPHONE COMMUNICATION, THE USER INFORMED THAT THE LEAKAGE WAS LEAKED FROM THE INSIDE OF THE INSTRUMENT AND COULD NOT BE SOLVED REMOTELY. THE ENGINEER NEEDED TO DEAL WITH IT ON SITE. THE USER WAS TOLD TO RE-TYPE 400 TO OPEN AN ON-SITE WORK ORDER. WORK ORDER NOTES((B)(4)): O SUBJECT / REPORTED: (B)(6) -ACCURI C6 PLUS-INSTRUMENT LEAKAGE. O PROBLEM DESCRIPTION: ACCURI C6 PLUS-THE INSTRUMENT IS LEAKING, THE RED PIPE IS BROKEN AND THE WASTE IS LEAKED. FOR SCIENTIFIC RESEARCH USE, THE QUOTATION HAS BEEN STAMPED AND SENT BACK. FOLLOW-UP CONTACT TEACHER (B)(6): (B)(6). O WORK PERFORMED: AFTER CLEARING THE BLOCKED PIPES AND JOINTS, DEBUG AND CALIBRATE, THE INSTRUMENT IS RUNNING NORMALLY, QC PASS. O CAUSE: BLOCKED FLUID PATH O SOLUTION: AFTER CLEARING THE BLOCKED PIPES AND JOINTS, DEBUG AND CALIBRATE, THE INSTRUMENT IS RUNNING NORMALLY, QC PASS. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO REPLACED PARTS. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000214703, REV. 5/VERS. A, BD ACCURI C6 FLOW CYTOMETER WITH OPTIONAL BD CSAMPLER PLUS RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES NO. O ID: (B)(6). O HAZARD EVENT: EXPOSURE TO BIO-HAZARDOUS MATERIAL DURING PREVENTATIVE MAINTENANCE. O CAUSE OF EVENT: USER SPILLS SAMPLE WASTE FLUID DURING PROCEDURE TO UNCLOG THE SIP, USING SYRINGE. O HARMFUL EFFECTS: EXPOSURE TO BIO HAZARDOUS MATERIAL O RISK CONTROLS: PCYT-648 ¿ LABELING BIOHAZARD. PCYT-3055 ¿ LABELING SIP BIOHAZARD SY-3126 ¿ SAFETY - BIOHAZARD. USER WILL APPLY THE UNIVERSAL PRECAUTION - INSTRUCTIONS FOR USE GUIDE - CHAPTER ON MAINTENANCE. WEAR SUITABLE PPE ¿ BIOLOGICAL SAFETY ¿ SAFETY AND LIMITATIONS GUIDE. IMPLEMENTATION VERIFICATION: MPI 7100279 ¿ MPI, ASSY., CASE, C6 23-18014-00 BD ACCURI¿ C6 PLUS SAFETY AND LIMITATIONS. MPI7100282 ¿ MPI, ASSY, SAMPLE STAGE, GEN-4. SEE PCYT-648. O EFFECTIVE VERIFICATION: SAME AS IMPLEMENTATION VERIFICATION. O PROBABILITY: 1. O SEVERITY: 4. O RISK INDEX: 4. O RESIDUAL RISK EVALUATION: A. O NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE WAS DUE TO A BLOCKAGE WITHIN THE FLUIDICS SYSTEM. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE WAS DUE TO A BLOCKAGE WITHIN THE FLUIDICS SYSTEM. THE FSE CONFIRMED THE ISSUE AND CLEANED THE FLUIDICS LINES TO CLEAR THE CLOGS AND BLOCKAGES. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED, AND FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR¿INJURED¿DUE TO THE INCIDENT, AND SINCE THE INSTRUMENT WAS NOT BEING USED FOR CLINICAL TREATMENT, NO PATIENTS WERE AFFECTED. THE SAFETY RISK IS SEVERE, S4, THOUGH THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ACCURI¿ IS LEAKING AND BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ACCURI C6 PLUS-THE INSTRUMENT IS LEAKING, AND THE RED PIPE IS BROKEN TO LEAK WASTE. RESEARCH USE 1 WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.):LIQUID 2 WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.):NOT CONTAINED 3 WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4):NO 4 WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5):BIOHAZARD 5 DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6):UNKNOWN 7 WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.:NO.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER PHONE #: (B)(6). 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 THAT BD ACCURI¿ IS LEAKING AND BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ACCURI C6 PLUS-THE INSTRUMENT IS LEAKING, AND THE RED PIPE IS BROKEN TO LEAK WASTE. RESEARCH USE WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED. IF NO, TYPE "NO") :NO. WHAT WAS THE FLUID THAT LEAKED?: BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE: UNKNOWN. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? IF NO, NO FURTHER QUESTIONS REQUIRED. PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147348 BD ACCURI NA GKL BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1