BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSVERSE

    MDR report key: 11526971 · Received March 19, 2021

    Report

    Report Number
    2916837-2021-00098
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 25, 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

    THE FOLLOWING FIELD WAS UPDATED DUE TO ADDITIONAL INFORMATION: H.6. IMDRF ANNEX G GRID: G04105 PUMP H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACSVERSE 3L 8C SYSTEM WITH ACC KIT, PART # 651155, SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING A LEAKAGE OF BIOHAZARD 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 25FEB2020 TO 25FEB2021. COMPLAINT TREND: THERE IS 5 COMPLAINT RELATED TO A LEAKAGE FROM THE SIT CAUSED BY A WORN PUMP. DATE RANGE FROM 25FEB2020 TO 25FEB2021. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 651155 SERIAL # (B)(6), FILE # 651155-651155-Z6511550109-900331938-12, 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 A WORN P2 PUMP. AFTER REPORTING THE ISSUE, THE CUSTOMER TRIED ADJUSTING THE PINCH VALVE TO FIX THE LEAK, BUT THIS DID NOT WORK. AN FSE (FIELD SERVICE ENGINEER) WAS BROUGHT ONSITE AND THEY CONFIRMED THAT THE LEAKAGE WAS DUE TO THE P2 PUMP (PN 647939). THE FSE REPLACED THE PUMP, VERIFIED THAT THERE WAS NO LEAKAGE AFTER THE SIT FLUSH, AND RAN CSTS TO CONFIRM THAT THE INSTRUMENT WAS WORKING AS EXPECTED. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. 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 #: 01816814, CASE # (B)(4) INSTALL DATE: 26APR2012 DEFECTIVE PART NUMBER: 647939 - P2 ASPIRATOR PUMP WORK ORDER NOTES: SUBJECT / REPORTED: DRIPPING FROM SIT WHEN REPLACING TUBE. PROBLEM DESCRIPTION: DRIPPING FROM SIT WHEN REPLACING TUBE. WORK PERFORMED: IMPLEMENTATION OF P2 PUMP REPLACEMENT WORK. AFTER REPLACEMENT, CHECK THAT THERE IS NO DRIPPING AFTER SIT FLUSH. OPERATION CHECK IS CARRIED OUT AT CST, AND ALL ARE PASSED. CAUSE: I HAVE CONFIRMED THE PHENOMENON. THIS IS DUE TO INSUFFICIENT SUCTION POWER OF THE SUCTION PUMP (P2 PUMP). SOLUTION: ALL CSTS HAVE PASSED. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE PART THAT WAS REPLACED 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 WORN P2 PUMP. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN P2 PUMP. THE FSE CONFIRMED THE ISSUE AND REPLACED THE PUMP. THEY THEN VERIFIED THAT THE INSTRUMENT WAS NO LONGER DRIPPING AFTER THE SIT FLUSH AND RAN CSTS. 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 MODERATE, 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 WASTE NOT MIXED WITH BLEACH LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DRIPPING FROM SIT WHEN REPLACING TUBE PLEASE CONFIRM THE SAFETY CHECK BELOW. 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. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. 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 WASTE NOT MIXED WITH BLEACH LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DRIPPING FROM SIT WHEN REPLACING TUBE PLEASE CONFIRM THE SAFETY CHECK BELOW. 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 WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429891 BD FACSVERSE NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1