BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSVERSE

    MDR report key: 11850807 · Received May 19, 2021

    Report

    Report Number
    2916837-2021-00245
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 28, 2021
    Report Date
    October 7, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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, SERIAL # (B)(6) . PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON A WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED WITHIN THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 28APR2020 TO DATE 28APR2021. COMPLAINT TREND: THERE ARE 17 COMPLAINTS RELATED TO THE ISSUE OF A WASTE LEAKAGE FROM THE SIT NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM 28APR2020 TO DATE 28APR2021. 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 LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS LIKELY FROM A WORN TUBING. THE CUSTOMER ORIGINALLY SUBMITTED THE COMPLAINT AND RECEIVED A PHONE CONSULTATION ((B)(4)) WHERE THE TSR (TECHNICAL SERVICE REPRESENTATIVE) HELPED CONFIRM THAT THERE WAS NO BLOCKAGE OF THE V8 VALVE. DURING (B)(4) AN FSE (FIELD SERVICE ENGINEER) WENT ONSITE TO PERFORM THE REPAIR, BUT FOUND THAT THE CUSTOMER HAD ALREADY COMPLETED THE REPAIR AND THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. THE FSE CONFIRMED THAT THE SIT WAS CLEAN, V8 PINCH TUBING HAD NO CLOGS OR BLOCKAGES, AND THAT THE ABORT CHECK PASSED. WHILE THE FSE SUSPECTS THAT THE LEAKAGE WAS DUE TO A FAULT IN THE FLUIDICS TUBING, THEY WERE NOT ABLE TO CONFIRM THAT THIS WAS THE CASE. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. 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 BLOCKED TUBING, 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: 04FEB2013. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: SUBJECT / REPORTED: 651155 - BD FACSVERSE - LEAKAGE FROM THE SIT DURING SIT FLUSH. PROBLEM DESCRIPTION: THE INSTRUMENT IS LEAKING FROM THE SIT WHEN A SIT FLUSH IS DONE. THE CUSTOMER ALSO NOTED THAT LIQUID IS SUCKED UP UNTIL JUST UNDER THE NEEDLE OF THE SIT AFTER ACQUISITION ENDS. WORK PERFORMED: CHECK SIT CLEAN. OK. CHECKED WASH VALVE @ TUBING OK. ABORT CHECK PASSED. INSTRUMENT READY. CAUSE: ALREADY SOLVED BY CUSTOMER. SOLUTION: SUSPECT ISSUE WITH TUBING. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WAS NO REPLACED PART. 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. (EXPOSURETO 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:BACKDRIPFROM 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, TUO 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 COULD NOT BE DETERMINED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE COULD NOT BE DETERMINED. ALTHOUGH AN FSE WAS BROUGHT ONSITE TO PERFORM THE REPAIR, THE CUSTOMER HAD ALREADY PERFORMED THE REPAIR AND THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. THE FSE VERIFIED THAT THE SIT WAS CLEAN, FLUIDICS TUBING WAS GOOD, AND THAT THE ABORT CHECK PASSED. WHILE THE FSE SUSPECTS THAT THE ISSUE WAS DUE TO FLUIDICS TUBING, THEY ARE NOT SURE WHAT THE EXACT CAUSE OF THE LEAKAGE WAS. NO ONE WAS HARMED ORINJUREDDUE 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACSVERSE¿ WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO PATIENT/USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT IS LEAKING FROM THE SIT WHEN A SIT FLUSH IS DONE. THE CUSTOMER ALSO NOTED THAT LIQUID IS SUCKED UP UNTIL JUST UNDER THE NEEDLE OF THE SIT AFTER ACQUISITION ENDS. 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION/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¿ WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO PATIENT/USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT IS LEAKING FROM THE SIT WHEN A SIT FLUSH IS DONE. THE CUSTOMER ALSO NOTED THAT LIQUID IS SUCKED UP UNTIL JUST UNDER THE NEEDLE OF THE SIT AFTER ACQUISITION ENDS. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/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
    749460 BD FACSVERSE NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1