BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC

    MDR report key: 12044480 · Received June 22, 2021

    Report

    Report Number
    2916837-2021-00284
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 28, 2021
    Report Date
    August 20, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 FACSLYRIC 3L10C INSTRUMENT, PART # 659180, SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT OF A WASTE LEAKAGE WITHOUT BLEACH DRIPPING FROM THE SIT OUTSIDE OF THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGES FROM 28MAY2020 TO DATE 28MAY2021. COMPLAINT TREND: THERE ARE 4 COMPLAINTS RELATED TO A LEAKAGE FROM THE SIT NOT CONTAINED WITHIN THE INSTRUMENT; DATE RANGES FROM 28MAY2020 TO DATE 28MAY2021. 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 LEAKAGE OF WASTE FROM THE SIT NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A PINCHED V8 PINCH VALVE. THE PINCH VALVE¿S DEFAULT STATE IS PINCHED SHUT, SO IF AN INSTRUMENT IS UNUSED FOR A PROLONGED AMOUNT OF TIME THIS TUBING WILL BE WORN, CLOSED SHUT OR NOT FULLY OPEN AND WILL HAVE TO EITHER BE EXERCISED/MASSAGED AND RECONNECTED OR REPLACED ENTIRELY. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THE ISSUE AND REPAIRED THE V8 PINCH VALVE TUBING BY REMOVING IT AND MASSAGING OUT THE PINCH. NO PARTS WERE REQUESTED FOR EVALUATION AS THE TUBING WAS NOT REPLACED. AFTER THE REPAIR THE INSTRUMENT WAS ABLE TO PROPERLY PERFORM THE SIT FLUSH, AND WAS PERFORMING AS EXPECTED WITH NO FURTHER LEAKS. ALTHOUGH LEAKAGE OF BIOHAZARD MATERIAL CAN CAUSE HARM TO THE CUSTOMER FROM EXPOSURE TO SAMPLES AND CHEMICALS, THE CUSTOMER WAS NOT HARMED IN ANY WAY FROM THIS INCIDENT AS THE LEAKAGE WAS MINIMAL. ADDITIONALLY, WHILE PATIENT SAMPLES WERE USED DURING THE TESTS THAT HAD LEAKAGES, THE RESULTS OF THESE TESTS WERE NOT USED FOR ANY DIAGNOSIS AND NO PATIENTS WERE HARMED IN ANY WAY. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED AND FUNCTIONING AS EXPECTED. 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)2021. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: SUBJECT / REPORTED: 659180 - FACSLYRIC 3L10C INSTRUMENT - AFTER REMOVING THE TUBE FROM THE MANUAL PORT IT DRIPS CONSIDERABLY. PROBLEM DESCRIPTION: AFTER REMOVING THE TUBE FROM THE MANUAL PORT, IT DRIPS CONSIDERABLY. WORK PERFORMED: REMOVED THE HOSE FROM V8 WITH THE CUSTOMER - THE HOSE STUCK TOGETHER ; MASSAGED FREELY AND INSERTED ANOTHER POINT, SIT FLUSH WORKS AGAIN. CAUSE: THE HOSE FROM V8 STUCK TOGETHER. SOLUTION: REMOVED THE HOSE FROM V8 WITH THE CUSTOMER - THE HOSE STUCK TOGETHER ; MASSAGED FREELY AND INSERTED ANOTHER POINT, SIT FLUSH WORKS AGAIN. INTERNAL NOTES: (B)(6) (B)(6) 2021 09: 14: 05Z: CLOSED, HELPDESK-AWAIT CUSTOMER RESPONSE CALLED (B)(6): REMOVED THE HOSE FROM V8 WITH THE CUSTOMER - THE HOSE STUCK TOGETHER ; MASSAGED FREELY AND REINSERTED ANOTHER POINT, SIT FLUSH WORKS AGAIN. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO PARTS REPLACED. RISK ANALYSIS: RISK MANAGEMENT FILE PART # (B)(4), REV. 03/VERS. X, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES/NO? TFS ID: (B)(4). ID: LIBIVD-RA-61 2.1.6. REG STATUS: IVD; RUO. HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. CAUSE: BACK DRIP FROM INJECTION PORT (SIT). HARMFUL EFFECTS: HARM TO OPERATOR. (EXPOSURE TO STAINED SAMPLE). RISK CONTROL: SIT DESIGN TO CAPTURE BACK DROPS. PROVIDE INSTRUCTION FOR UNIVERSAL PRECAUTIONS. REG LINK (TFS ID): 93132 LIBIVD-DID-262 SAMPLE PRESERVATION DURING PAUSE. IMPLEMENTATION VERIFICATION: LSVN-1008-DP SIT BACKFLOW CONTROL, LIBIVD-SE-15-51IR. EFFECTIVENESS VERIFICATION: LSVN-1008-DR, LIBIVD-SE-15-51IR. PROBABILITY: 1. SEVERITY: 3. RISK INDEX: 3. RESIDUAL RISK EVALUATION: A. NEW HAZARDS: NONE. TFS ID: (B)(4). ID: LIBIVD-RA-247 3.1.25. REG STATUS: IVD; RUO. HAZARD: INSTRUMENT TEMPORARILY INOPERABLE. SOURCE: SIT FMEA. CAUSE: SAMPLE LINE COLLAPSES PREVENTING SAMPLE DELIVERY. TUBING BECOMES WORN/DAMAGED DURING "STINGER" OPERATION. LOW EVENT RATE. HARMFUL EFFECTS: 1) DELAY IN RESULTS. 2) TUBING MUST BE REPLACED. 3) CUSTOMER ANNOYANCE. RISK CONTROL: PROPER SERVICE LOOPS FOR PEEKSIL TUBE SO THAT IT DOES NOT WEAR AND KINK AT THE CONNECTION POINTS. RELIABILITY TEST TO PROVIDE ESTIMATE LIFE OF PEEKSIL TUBE AND RECOMMENDED REPLACEMENT SCHEDULE. RELIABILITY SIT PROTOCOL. REG LINK (TFS ID): N/A. IMPLEMENTATION VERIFICATION: RELIABILITY LIFE TESTING COMPLETED VIA PROTOCOL. PROTOCOL NAME: LIBERTY SIT RELIABILITY TEST PROTOCOL. LIBIVD-SE-15-72P. EFFECTIVENESS VERIFICATION: PUBLISHED RELIABILITY REPORT WHICH DEMONSTRATED AT LEAST 1.5 YEARS OF LIFE WITH NO SIGNIFICANT DAMAGE OR KINKS. REPORT NAME: LIBERTY SIT RELIABILITY REPORT. LIBIVD-SE-15-72F. PROBABILITY: 2. SEVERITY: 2. RISK INDEX: 4. 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 PINCHED V8 TUBING. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A PINCHED V8 TUBING. THE FSE CONFIRMED THE ISSUE, REMOVED THE HOSE FROM THE V8 PINCH VALVE TO MASSAGE THE PINCH OUT, AND REATTACHED THE TUBING. AFTER THE REPAIR THE INSTRUMENT WAS ABLE TO RUN THE SIT FLUSH PROPERLY, AND THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE LEAKAGE. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO THE CUSTOMER HEALTH OR SAFETY. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: AFTER REMOVING THE TUBE FROM THE MANUAL PORT, IT DRIPS CONSIDERABLY. 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? YES, FACSFLOW UNDER PRESSURE. 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

    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 WHILE USING BD FACSLYRIC¿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: AFTER REMOVING THE TUBE FROM THE MANUAL PORT, IT DRIPS CONSIDERABLY. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? YES, FACSFLOW UNDER PRESSURE. 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
    943686 BD FACSLYRIC NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1