BD FACSLYRIC
Report
- Report Number
- 2916837-2021-00214
- Event Type
- Malfunction
- Date Received
- May 3, 2021
- Date of Event
- April 13, 2021
- Report Date
- September 28, 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
H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L8C INSTRUMENT, PART # 654587, 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 13APR2020 TO DATE 13APR2021. ¿ COMPLAINT TREND: THERE ARE 7 COMPLAINTS RELATED TO THE LEAKAGE OF BIOHAZARD 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 #654587 SERIAL # (B)(6). FILE # 654587-654587-R654587000039-106010831-18, 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 LIKELY DUE TO A DIRTY FLUIDICS SYSTEM. DIRT, DEBRIS, AND CLOGS IN THE FLUIDICS SYSTEM CAN CONTRIBUTE TO FLOWRATE, BACKFLOW, AND ASPIRATION ISSUES LEADING TO ERRONEOUS RESULTS OR LEAKAGES. THE CUSTOMER HAD SUBMITTED THE COMPLAINT REGARDING THEIR INSTRUMENT DRIPPING FROM THE SIT WHICH HAS BEEN ONGOING FOR SEVERAL WEEKS. WITHIN THE CASE COMMENTS (01318826) THE FIELD ENGINEER THAT ASSISTED THE CUSTOMER EXPLAINED THAT MONTHLY CLEANINGS AND ADJUSTMENTS TO THE PINCH VALVE HAVE BEEN REPEATED EVERY MONTH, AND SOMETIMES THE DRIPPING WILL PERSIST. THEY GO ON TO SAY NEXT MONTHLY CLEANING, THEY WILL SUCK DI WATER INTO THE PINCH VALVE WITH A SIT FLUSH. THE CUSTOMER MANAGED TO COMPLETE THIS REPAIR WITHOUT THE HELP OF AN FSE (FIELD SERVICE ENGINEER) AND THE INSTRUMENT WAS REPORTED TO BE FUNCTIONING AS EXPECTED. 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. PROPER SCHEDULED CLEANING AND OTHER MAINTENANCE CAN HELP IN MAINTAINING A FUNCTIONAL FLUIDICS SYSTEM, AND INSTRUCTIONS CAN BE FOUND IN CHAPTER 13 OF THE BD FACSLYRIC¿ CLINICAL SYSTEM INSTRUCTIONS FOR USE (#23-19938-02 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 #: N/A, CASE # 01318826 INSTALL DATE: 20SEP2019 DEFECTIVE PART NUMBER: N/A CASE COMMENTS: O (4/13/2021 3:06AM) DRIPPING FROM SIT O (4/13/2021 3:07AM) [PHENOMENON] DRIPPING FROM SIT. [CORRESPONDENCE] REGARDING FACSLYRIC, WE HAVE CONTACTED YOU BECAUSE THE PHENOMENON OF LIQUID DRIPPING FROM THE SIT NOZZLE THAT HAS OCCURRED FOR SOME TIME HAS REAPPEARED. THE SYMPTOM HAS BEEN GOING ON FOR 2 WEEKS, AND EVEN IF I DO SIT FLUSH, IT DOESN'T GO AWAY. I HAD YOU REPLACE THE WASTE LIQUID LINE WITH THE SAME SYMPTOM IN JANUARY. WILL THIS BE THE CASE AGAIN? O (4/19/2021 11:02AM) WE WILL INFORM YOU HOW TO DEAL WITH IT BY E-MAIL. I RECEIVED A REPLY ON APRIL 16TH. I HAD THE COVER OPEN AND REATTACHED THE PINCH TUBE TO RECOVER, BUT I AM DOING MONTHLY CLEANING EVERY MONTH, AND AFTER THAT I OFTEN HAVE SYMPTOMS. SIT FLUSH MAY BE FIXED MULTIPLE TIMES, BUT IT MAY NOT BE IMPROVED LIKE THIS TIME. I USE IT ALMOST EVERY DAY FOR CLINICAL TRIALS. AFTER MONTHLY CLEANING, PURGE SHEATH FILTER SEEMS TO HAVE BEEN COMPLETED, SO NEXT TIME, AFTER MONTHLY CLEANING, WE WILL SUCK DI WATER INTO THE PINCH TUBE LINE WITH SIT FLUSH. TRACKWISE COMMENTS (PR 2745866): O (4/21/2021): AFTER MONTHLY CLEANING, THE CUSTOMER USED SIT FLUSH TO SUCK DI WATER INTO THE PINCH TUBE LINE. THE CUSTOMER CURRENTLY USES THE INSTRUMENT AS USUAL. NO MORE ACTION IS PLANNED AS OF NOW. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO PARTS REPLACED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058, 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 O TFS ID: 89169¿¿¿¿¿ O ID: LIBIVD-RA-61 2.1.6¿¿¿¿¿ 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 DROPS. PROVIDE INSTRUCTION FOR UNIVERSAL PRECAUTIONS.¿¿¿¿¿ O REG¿LINK (TFS 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 LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS LIKELY DUE TO A DIRTY FLUIDICS SYSTEM. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS LIKELY DUE TO A DIRTY FLUIDICS SYSTEM. THE INSTRUMENT WAS REPORTED TO HAVE BEEN DRIPPING FOR SEVERAL MONTHS AND SIT FLUSHES WERE NOT RESOLVING THE ISSUE. A FIELD ENGINEER RECOMMENDED THE CUSTOMER RUN THE MONTHLY CLEANING AND THEN SUCK DI WATER INTO THE PINCH TUBE LINE WITH A SIT FLUSH WHICH RESOLVED THE ISSUE. NO ONE WAS HARMED OR¿INJURED¿DUE TO THE INCIDENT, AND NO PATIENTS WERE AFFECTED AS THE RESULTS WERE NOT USED FOR TREATMENT.¿THE SAFETY RISK IS¿MODERATE, S3, AND¿THERE¿WAS NO¿IMPACT TO¿CUSTOMER¿HEALTH OR SAFETY. H3 OTHER TEXT : SEE H.10
IT WAS REPORTED WHILE USING BD FACSLYRIC¿ BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AFTER MONTHLY CLEANING, THE CUSTOMER USED SIT FLUSH TO SUCK DI WATER INTO THE PINCH TUBE LINE. 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 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD FACSLYRIC" BIOHAZARDOUS 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 MONTHLY CLEANING, THE CUSTOMER USED SIT FLUSH TO SUCK DI WATER INTO THE PINCH TUBE LINE. 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 CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663744 | BD FACSLYRIC | NA | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |