BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSVERSE

    MDR report key: 11483176 · Received March 15, 2021

    Report

    Report Number
    2916837-2021-00086
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 17, 2021
    Report Date
    September 21, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 FACSVERSE 3L 8C SYSTEM WITH ACC KIT, PART # 651155 AND SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT ON A BIOHAZARD LEAKAGE FROM THE SIT NOT CONTAINED WITHIN THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM (B)(6) 2020 TO DATE (B)(6) 2021. COMPLAINT TREND: THERE ARE 12 COMPLAINTS RELATED TO A LEAKAGE FROM THE SIT NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM (B)(6) 2020 TO DATE (B)(6) 2021. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #651155 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 LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOGGED P2 PUMP. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THE ISSUE, READJUSTED THE V8 PINCH VALVE TUBING, AND REPLACED THE P2 PUMP. THEY THEN ADJUSTED THE OPTICAL PATH AND DELAY, OBSERVED THE PATTERN SHOWN WITH RAINBOW BEADS, AND RAN QC TESTS. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. AFTER THE REPAIR THE INSTRUMENT WAS FUNCTIONING 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 CLOGS WITHIN THE FLUIDICS SYSTEM, AND INSTRUCTIONS CAN BE FOUND IN CHAPTER 9 OF THE BD FACSVERSE¿ CLINICAL SYSTEM INSTRUCTIONS FOR USE (#23-11463-00 REV. 1/VERS. A). THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4), CASE # (B)(4). INSTALL DATE: (B)(6) 2013. DEFECTIVE PART NUMBER: 641925 - PUMP PRIMING P2 MAIN SYSTEM. WORK ORDER NOTES: SUBJECT / REPORTED: LIQUID DRIPS FROM SIT WHEN THE TUBE IS REPLACED; DESCRIPTION: LIQUID DRIPS FROM SIT WHEN THE TUBE IS REPLACED; WORK PERFORMED: * PINCH VALVE (V8) PART SILICON TUBE ADJUSTMENT. * P3 PUMP REPLACEMENT. * EACH LASER HOME POSITION IS IMPLEMENTED. * OPTICAL AXIS ADJUSTMENT. * EACH DELAY ADJUSTMENT. * CHECK THE PATTERN WITH RAINBOW BEADS. * QUALITY CONTROL IMPLEMENTATION (CQC, PQC IMPLEMENTATION ALL-PASS). * THERE IS NO PROBLEM WITH THE ABORT COUNT. CAUSE: DUE TO CLOGGING OF THE PUMP. SOLUTION: * YOU CAN USE IT WITHOUT ANY PROBLEM. 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 # 651155RA, REV. 11/VERS. B, LIBERTY RUO 1.0 RESEARCH SYSTEMS (FACSVERSE) RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES. NO. HAZARD ID: 2.1.8B. HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. CAUSE: BACKDRIP FROM INJECTION PORT. HARMFUL EFFECTS: HARM TO OPERATOR. (EXPOSURE TO STAINED SAMPLE). RISK CONTROLS: SIT FLUSH DESIGN TO CAPTURE BACK DRIPS. LIB-FLD-292 LIB-FLD-312, LIB-FLD-313, PROVIDE INSTRUCTION AND UNIVERSAL PRECAUTIONS. IMP. VERIF.: SIT BACK FLOW CONTROL PROTOCOL LSV-1008-DP, SAMPLE CARRYOVER: SV-1013-DP, SLG: BIOLOGICAL SAFETY SECTION. EFF. VERIF.: SIT BACK FLOW CONTROL LSV-1008-TR, SAMPLE CARRYOVER: SV-1013-DR. PROBABILITY: 1. SEVERITY: 1. RISK INDEX: 1. RESIDUAL RISK EVALUATION: A. NEW HAZARDS: NONE. HAZARD ID: 2.1.9B. HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. CAUSE: BACKDRIP FROM INJECTION PORT. HARMFUL EFFECTS: DEGRADED INSTRUMENT PERFORMANCE (SENSORS, MOVING PARTS) REQUIRING FSE VISIT TO REPAIR DAMAGES. RISK CONTROLS: SIT FLUSH DESIGN TO CAPTURE BACK DRIPS. LIB-FLD-292 LIB-FLD-312, LIB-FLD-313 PROPER SHIELDING (SKINS, UAL SPLASH GUARD) OF CRITICAL COMPONENTS, SURFACES. IMP. VERIF.: SIT BACK FLOW CONTROL PROTOCOL LSV-1008-DP, SAMPLE CARRYOVER: SV-1013-DP, FLUIDIC MANAGEMENT LSVN1034-DP, CHEMICAL COMPATIBILITY OF METALS: LSVN1027-TP, RUO INSTRUMENT SKINS COVER KIT# 650669 AND IVD INSTRUMENT SKINS COVER KIT# 650670 EFF. VERIF.: SIT BACK FLOW CONTROL LSV-1008-TR, SAMPLE CARRYOVER: SV-1013-DR, FLUIDIC MANAGEMENT: LSVN1034-DR, CHEMICAL COMPATIBILITY OF METALS: LSVN1027-TR. PROBABILITY: 1. SEVERITY: 3. RISK INDEX: 3. RESIDUAL RISK EVALUATION: A. NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT : YES. NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOGGED P2 PUMP. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOGGED P2 PUMP. THE FSE READJUSTED THE V8 PINCH VALVE TUBING AND REPLACED THE WORN P2 PUMP. THEY THEN ALIGNED THE OPTICAL PATH AND TESTED THE INSTRUMENT TO VERIFY IT WAS WORKING AS INTENDED. 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 ISMODERATE, S3, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACSVERSE¿ BIOHAZARDOUS FLUID LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AFTER THE USER REPLACES THE TUBE, THE LIQUID SLOWLY DRIPS. IT DOES NOT AFFECT THE MEASUREMENT, BUT I WOULD LIKE YOU TO COME AND SEE IT. SLOW BUT LEAKING FROM THE SIT PART. 1. WAS THE LEAK FLUID OR AIR? FLUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 FACSVERSE¿ BIOHAZARDOUS FLUID LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER THE USER REPLACES THE TUBE, THE LIQUID SLOWLY DRIPS. IT DOES NOT AFFECT THE MEASUREMENT, BUT I WOULD LIKE YOU TO COME AND SEE IT. SLOW BUT LEAKING FROM THE SIT PART. WAS THE LEAK FLUID OR AIR? FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387268 BD FACSVERSE NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1