BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 13594270 · Received February 24, 2022

    Report

    Report Number
    2916837-2022-00040
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    February 7, 2022
    Report Date
    April 4, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    K201814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L10C INSTRUMENT, PART # 659180, SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT OF 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 08FEB2021 TO DATE 08FEB2022. COMPLAINT TREND: THERE ARE 21 COMPLAINTS RELATED TO A LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT; THESE COMPLAINTS CAN BE FOUND IN THE ATTACHED COMPLAINTS TREND FILE. DATE RANGE FROM 08FEB2021 TO DATE 08FEB2022. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #659180 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 A BLOCKAGE IN THE V8 VALVE WASTE LINE. THE CUSTOMER HAD INITIALLY REPORTED THAT THE SIT WAS NOT ASPIRATING AFTER THE SIT FLUSH PROTOCOL AND AN FSE (FIELD SERVICE ENGINEER) WAS SENT ONSITE TO OBSERVE THE ISSUE. THE FSE RAN CAMERA DIAGNOSTICS AND CLEARED THE CLOG FROM THE V8 VALVE TUBING. THEY THEN CALIBRATED THE OPTICS AND RAN A PQC TEST WITH POSITIVE RESULTS. AFTER THE REPAIRS THE INSTRUMENT WAS FUNCTIONING AS EXPECTED WITH NO FURTHER LEAKAGES. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. ALTHOUGH A LEAKAGE OF WASTE MATERIAL POSES A HAZARD OF CONTAMINATION UPON CONTACT, THE CUSTOMER CONFIRMED THAT THEY WERE NOT HARMED IN ANY WAY. ADDITIONALLY, THE LEAKAGE WAS NOT UNDER PRESSURE AND THUS DID NOT INCREASE THE RISK OF EXPOSURE. PROPER DAILY AND MONTHLY CLEANING AND MAINTENANCE CAN HELP IN MAINTAINING AN OPTIMAL SYSTEM, AND CAN BE FOUND IN THE BD FACSLYRIC¿ CLINICAL SYSTEM INSTRUCTIONS FOR USE, #23-19938-02 REV. 1/VERS. A. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4), CASE #(B)(4). INSTALL DATE: (B)(6) 2021. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: SUBJECT / REPORTED: DRIPPING FROM THE NEEDLE DURING THE SIT FLUSH. PROBLEM DESCRIPTION: THE USER REPORTS THAT THE MATERIAL FROM THE NEEDLE IS NOT SUCTIONED WHEN STARTING THE SIT FLUSH PROCEDURE. SERVICE VISIT REQUIRED. WORK PERFORMED: CAMERA DIAGNOSTICS. CLEAN CLOGGED WASTE LINE ON VALVE V8. TUNING OF THE OPTICAL SYSTEM. POSITIVE PQC CONTROL RESULTS. THE DEVICE IS OPERATIONAL IN ACCORDANCE WITH THE TECHNICAL DOCUMENTATION. THE RECOMMENDED DATE OF THE PERIODIC INSPECTION REMAINS UNCHANGED, IE AUGUST 17, 2022. CAUSE: WASTE LINE BLOCKED AT VALVE V8. SOLUTION: N/A. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO REPLACED PARTS. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058RA, REV. 06/VERS. Z, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO O AZURE ID: 89169. O ID: (B)(4). O REG STATUS: IVD; RUO. O HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. O CAUSE: BACK DRIP FROM INJECTION PORT (SIT). O HARMFUL EFFECTS: HARM TO OPERATOR. (EXPOSURE TO STAINED SAMPLE). O RISK CONTROL: - SIT DESIGN TO CAPTURE BACK DRIPS. - PROVIDE INSTRUCTION FOR UNIVERSAL PRECAUTIONS. O REQ LINK (AZURE ID): 93132 LIBIVD-DID-262 SAMPLE PRESERVATION DURING PAUSE. O IMPLEMENTATION VERIFICATION: - LSVN-1008-DP SIT BACKFLOW CONTROL. - LIBIVD-SE-15-51IR. O EFFECTIVENESS VERIFICATION: - LSVN-1008-DR. - LIBIVD-SE-15-51IR. 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 OF THE WASTE LEAKAGE WAS DUE TO A BLOCKED WASTE TUBING. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE WAS DUE TO A BLOCKED WASTE TUBING. THE FSE RAN CAMERA DIAGNOSTICS, CLEARED THE CLOG IN THE V8 VALVE WASTE LINE, AND CALIBRATED THE OPTICS. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED, AND FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE LEAKAGE. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. SUPPORTING DOCUMENT: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD FACSLYRIC¿ WAS LEAKING BIOHAZARDOUS FLUID OUTSIDE OF THE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DRIPPING FROM THE NEEDLE. IS THE LEAK FLUID OR AIR? THERE WAS NO LEAK. THE FLUID WAS DRIPPING FROM THE END OF CAPILLARY ON SIT. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? DRIPPING WAS NOT CONTAINED WITHIN THE INSTRUMENT. WAS THE FLUID ACTIVELY SPRAYING ABOUT OUTSIDE THE MACHINE? NO. IS LEAKED LIQUID TYPE KNOWN? BIOHAZARDOUS OR NON-BIOHAZARDOUS? DRIPPING WAS A MIX OF BIOHAZARDOUS FLUID AND FACSFLOW. DID THE LEAKED LIQUID HAVE BLEACH MIXED IN? NO. WAS ANYONE INJURED DUE TO THE LEAKED LIQUID? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD FACSLYRIC¿ WAS LEAKING BIOHAZARDOUS FLUID OUTSIDE OF THE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM POLISH TO ENGLISH: DRIPPING FROM THE NEEDLE. 1. IS THE LEAK FLUID OR AIR? THERE WAS NO LEAK. THE FLUID WAS DRIPPING FROM THE END OF CAPILLARY ON SIT. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? DRIPPING WAS NOT CONTAINED WITHIN THE INSTRUMENT. 3. WAS THE FLUID ACTIVELY SPRAYING ABOUT OUTSIDE THE MACHINE? NO. 4. IS LEAKED LIQUID TYPE KNOWN? BIOHAZARDOUS OR NON-BIOHAZARDOUS? DRIPPING WAS A MIX OF BIOHAZARDOUS FLUID AND FACSFLOW. 5. DID THE LEAKED LIQUID HAVE BLEACH MIXED IN? NO. 6. WAS ANYONE INJURED DUE TO THE LEAKED LIQUID? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109353 BD FACSLYRIC¿ NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown