BD FACSLYRIC¿
Report
- Report Number
- 2916837-2021-00459
- Event Type
- Malfunction
- Date Received
- November 22, 2021
- Date of Event
- October 29, 2021
- Report Date
- February 2, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
H.6. INVESTIGATION: 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 REGARDING HIGH CARRY OVER BETWEEN SAMPLES. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 29OCT2020 TO DATE 29OCT2021. COMPLAINT TREND: THERE ARE 15 COMPLAINTS RELATED TO THE ISSUE OF HIGH CARRY OVER. DATE RANGE FROM 29OCT2020 TO DATE 29OCT2021. 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 CARRYOVER COULD NOT BE DETERMINED. THE CUSTOMER HAD REPORTED THAT SINCE THE UPGRADE TO THE FACSUITE 1.5 SOFTWARE, THEY HAD NOTICED MORE CARRYOVER BETWEEN SAMPLE TUBES. AN FSE (FIELD SERVICE ENGINEER) ARRIVED ONSITE TO DISCUSS THE ISSUE AND TEST THE INSTRUMENT WITH THE CUSTOMER. THE FSE CHECKED THE SAMPLE VOLUMES, CHECKED THE DEFAULT NUMBER OF SIT FLUSHES, AND SET UP EXPERIMENTS IN FACSUITE TO OBSERVE THE GATED STATISTICS OVER BEAD POPULATION. IT WAS CONFIRMED THAT NO EVENTS WERE IN THE P1 GATE DURING THE SIT FLUSH. THE LENGTH OF THE SIP WAS DETERMINED TO BE TOO LONG SO IT WAS REDUCED WITH THE SIP CALIBRATION TOOL, AND THIS ADJUSTMENT OF THE SIP ALSO REQUIRED ADJUSTMENTS TO THE MTLP ZREF VALUE. AFTER ASSESSING THE SYSTEM THE CUSTOMER RAN TESTS WITH THE INSTRUMENT, AND IT SEEMED TO BE FUNCTIONING AS EXPECTED. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. ALTHOUGH THE SIP LENGTH WAS INCORRECT, THE TESTS RUN BY THE FSE PRIOR TO THE ADJUSTMENT COMPLETED SUCCESSFULLY AND SHOULD NOT HAVE BEEN THE CAUSE OF THE CARRYOVER. THE FSE WAS UNABLE TO REPLICATE THE CARRYOVER, BUT COMMENTED THAT IT POSSIBLY WAS DUE TO INTERMITTENT SIT FLUSH ISSUES. ALTHOUGH THE UNEXPECTED RESULTS WERE FROM PATIENT SAMPLES FOR CLINICAL USE, NO PATIENT WAS TREATED NOR HARMED FROM INCORRECT RESULTS. THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSIS DECISION AND WAS REPORTED TO BD AS NOT EXPECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. PROPER DAILY AND MONTHLY CLEANING PROCEDURES CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD FACSLYRIC¿ CLINICAL SYSTEM INSTRUCTIONS FOR USE, #23-19938-02 REV. 1/VERS. A, PAGE 165. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4), CASE # (B)(4). INSTALL DATE: (B)(6) 2018. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: SUBJECT / REPORTED: 659180 - FACSLYRIC - CARRYOVER ISSUE. PROBLEM DESCRIPTION: CUSTOMER REPORTS THAT SINCE THE UPGRADE TO FACSUITE 1.5 SHE HAS NOTED MORE CARRYOVER BETWEEN TUBES. SHE IS ASKING WHETHER THE SOFTWARE STILL MAKES SIT FLUSHES BETWEEN SAMPLES. CUSTOMER HAD TO RE-RUN A TUBE BECAUSE OF AN ERRONEOUS RESULT. WORK PERFORMED: (B)(4) 1ST NOVEMBER 2021 - ARRIVED ONSITE AND DISCUSSED REPORTED ISSUE WITH CUSTOMER, CHECK WITH CUSTOMER SAMPLE VOLUME DOES NOT EXCEED 700UL AS IT¿LL CONTACT OUTER PROBE AND CAN LEAD TO CARRYOVER. CHECKED DEFAULT NUMBER OF SIT FLUSH = 1. PROCEEDED TO SET UP EXPERIMENT IN FACSUITE, ACQUIRED TUBE OF TRUCOUNT BEADS FOR 1 MINUTE AND GATED STATISTICS OVER BEAD POPULATION. RAN SIT FLUSH, ACQUIRED TUBE OF DI WATER FOR 1 MINUTE AND CONFIRMED NO EVENTS IN P1 GATE. RAN TEST NUMEROUS TIMES SUCCESSFULLY. INSPECTION OF SAMPLE LINE PEEK TUBING ASSESSED LENGTH EXTENDED FROM METAL SIP IS TOO LONG, REDUCED AND SET WITH SIP CALIBRATION TOOL. REDUCED INCREASED DEAD VOLUME AS A CONSEQUENCE OF SAMPLE LINE ADJUSTMENT BY LOWERING MTLP ZREF VALUE SO SAMPLE LINE IS STILL LOW IN SAMPLE TUBE. CHECKED V8 VALVE AND TUBING OPERATION OK. CUSTOMER RAN CLINICAL SAMPLE IN A WORKLIST AND FOLLOWED BY A TUBE OF DI WATER, NO CELLS WERE RECORDED IN THE DI WATER TUBE. SATISFIED SAMPLE SIT FLUSH IS OPERATING CORRECTLY. RAN ABORT COUNT CHECK FLYR19-28, PASSED. DISCUSSED INTERVENTION WITH CUSTOMER AND SUGGESTED TO INCREASE DEFAULT NUMBER OF SIT FLUSHES BETWEEN SAMPLES IN WORKLIST, SEEKING APPLICATIONS ADVICE ON HOW TO IMPLEMENT. CAUSE: UNKNOWN - POSSIBLE INTERMITTENT SIT FLUSH ISSUE. SOLUTION: TESTED SAMPLE SIT FLUSH OPERATION EXTENSIVELY WITH TRUCOUNT BEADS AND CLINICAL SAMPLES. UNABLE TO REPLICATE ISSUE. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE NO PARTS WERE REPLACED. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058, 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. AZURE ID: 89236. ID: LIBIVD-RA-256 3.1.34 REG STATUS: IVD; RUO HAZARD: INCORRECT DATA. SOURCE: FLOW CELL FMEA CAUSE: TUBING OR PORT DETAIL DIAMETERS AT SPEC EXTREMES, CAUSING MISALIGNMENT. HARMFUL EFFECTS: 1. UNACCEPTABLE CARRYOVER2. POTENTIAL INCORRECT RESULTS RISK CONTROL: SAMPLE CARRYOVER TESTING TO CONFIRM THE SAMPLE CARRYOVER LEVEL TO SPECIFICATIONS. REQ LINK (AZURE ID): N/A. IMPLEMENTATION VERIFICATION: LSVN-1013-DP SAMPLE CARRYOVER. EFFECTIVENESS VERIFICATION: LSVN-1013-DR. 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 CARRYOVER BETWEEN SAMPLE TESTS COULD NOT BE DETERMINED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE CARRYOVER BETWEEN SAMPLE TESTS COULD NOT BE DETERMINED. THE FSE INSPECTED THE INSTRUMENT AND THE ONLY ABNORMALITY FOUND WAS A LONG SIP LENGTH. THE SIP WAS REDUCED WITH THE SIP ADJUSTMENT TOOL, THE INSTRUMENT WAS TESTED, AND IT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE SIP LENGTH WAS INCORRECT, TESTS PRIOR TO THE ADJUSTMENT COMPLETED SUCCESSFULLY AND THUS IT SHOULD NOT HAVE BEEN THE CAUSE OF THE CARRYOVER. AFTER THE INSPECTION AND TESTS, THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY.
IT WAS REPORTED THAT WHILE RUNNING BD FACSLYRIC¿ CARRYOVER OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT SINCE THE UPGRADE TO FACSUITE 1.5 SHE HAS NOTED MORE CARRYOVER BETWEEN TUBES. SHE IS ASKING WHETHER THE SOFTWARE STILL MAKES SIT FLUSHES BETWEEN SAMPLES. CUSTOMER HAD TO RE-RUN A TUBE BECAUSE OF AN ERRONEOUS RESULT.
IT WAS REPORTED THAT WHILE RUNNING BD FACSLYRIC¿ CARRYOVER OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT SINCE THE UPGRADE TO FACSUITE 1.5 SHE HAS NOTED MORE CARRYOVER BETWEEN TUBES. SHE IS ASKING WHETHER THE SOFTWARE STILL MAKES SIT FLUSHES BETWEEN SAMPLES. CUSTOMER HAD TO RE-RUN A TUBE BECAUSE OF AN ERRONEOUS RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1756010 | BD FACSLYRIC¿ | NA | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |