BD FACSLYRIC¿
Report
- Report Number
- 2916837-2023-00022
- Event Type
- Malfunction
- Date Received
- February 8, 2023
- Date of Event
- January 13, 2023
- Report Date
- April 26, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- UDI-DI
- 00382906628787
- PMA / PMN Number
- K170974
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
COMMON DEVICE NAME: FLOW CYTOMETRIC REAGENTS AND ACCESS. (B)(6). PMA / 510(K) #: K170974, K201814. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L10C INSTRUMENT US, PART # 662878, SERIAL # (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING CARRYOVER THAT OCCURRED ON (B)(6) 2023. CARRYOVER POSES THE RISK OF PRODUCING ERRONEOUS RESULTS THAT MIGHT IMPACT PATIENT DIAGNOSIS AND TREATMENT. THE INSTRUMENT WAS REPAIRED AND FOUND TO BE FUNCTIONING AS EXPECTED, AND NO USERS OR PATIENTS WERE HARMED DUE TO THIS ISSUE. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE FOR PART # 662878. DATE RANGE FROM (B)(6) 2022 TO DATE (B)(6) 2023. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 662878, SERIAL # (B)(6), FILE # (B)(4) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ COMPLAINT HISTORY REVIEW: THERE ARE 2 COMPLAINTS RELATED TO THE ISSUE OF CARRYOVER (AS REPORTED CODE 1: ¿CONTAMINATION ¿ CARRY OVER¿) FOR PART # 662878. DATE RANGE FROM (B)(6) 2022 TO DATE (B)(6) 2023. ¿ RETURNED SAMPLE ANALYSIS: A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION BECAUSE THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. ¿ SERVICE HISTORY REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4); CASE #: (B)(4) INSTALL DATE: (B)(6) 2018 DEFECTIVE PART NUMBER(S): 34350807 - BARBED FITT 1/16 ID TUBING SERVICE WO (B)(4) - FIELD SERVICE NOTES: O SUBJECT / REPORTED: CARRY OVER ISSUE O PROBLEM DESCRIPTION: CARRY OVER ISSUE O WORK PERFORMED: * PERFORMED 'SIT FLUSH" - SIT DRIPPED SHEATH FLUID - DID NOT ASPIRATE TO WASTE. * SEE "MDR SAFETY CHECKLIST - LEAK". * REMOVED FLUIDIC SIDE PANEL. * REMOVED TUBING FROM (V8) - NO INDICATION OF "KINK" IN TUBING - PLACED TUBING BACK IN (V8). * OPENED SIT DOOR - NOTED SIT ARM FLUSH BARB FITTING (34350807) HAD CRACKED - CREATING A AIR LEAK CAUSING SIT FLUSH FAILURE. * REPLACED BARB FITTING ((B)(4)). * RAN TUBE OF FITC BEADS FOLLOWED BY TUBE OF PE BEADS ALTERNATING NUMEROUS TIMES - NO CARRYOVER > 0.05% * VERIFIED INSTRUMENT PERFORMANCE. * RAN PQC = PASSED. * CUSTOMER'S WORKSTATION USB PORTS LOCKED - NO PQC REPORT ATTACHED. * RAN ABORT COUNT = 0% O CAUSE: CRACKED SIT FLUSH BARB FITTING - CREATING A AIR LEAK AND SIT FLUSH FAILURE. O SOLUTION: INSTRUMENT RUNNING AS DESIGNED. O PART(S) REPLACED: 34350807 - BARBED FITT 1/16 ID TUBING SERVICE WO-(B)(4) ¿ ESCALATION NOTES: O ((B)(6) 2023 21:32:14 GMT) CRACKED SIT WASTE FITTING- CREATING A AIR LEAK AND SIT FLUSH FAILURE. BARB FITTING (34350807) HAS BEEN REPLACED. TO BE CONFIRMED. O ((B)(6) 2023 15:21:14 GMT) MOVING TO EP-0278 EP-0278 NOTES: O PROJECT NAME: LYRIC SIT DRIP/CARRYOVER O ((B)(6) 2023) PRODUCT ENGINEERING TEAM IS CONDUCTING TESTING ON NEW TUBING/VALUES. RESULTS EXPECTED 1ST WEEK OF MARCH ¿ LABELING / PACKAGING REVIEW: N/A ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058RA, REV. 08/VERS. AB, 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: (B)(6) O HAZARD ID: (B)(6) O HAZARD: INCORRECT OUTPUT FOR SAMPLES UP TO 1.5ML OR LESS. O CAUSE: SAMPLE CARRYOVER ERROR - FLUIDIC. O HARMFUL EFFECTS: EVENTS APPEAR IN WRONG TUBE (FALSE POSITIVE RESULT). O RESIDUAL PROBABILITY: 1 O RESIDUAL SEVERITY: 3 O RESIDUAL RISK INDEX: 3 O AZURE ID: (B)(6) O HAZARD ID: (B)(6) O HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. O CAUSE: BACK DRIP FROM INJECTION PORT. O HARMFUL EFFECTS: WRONG RESULTS BY CROSS CONTAMINATION. O RESIDUAL PROBABILITY: 1 O RESIDUAL SEVERITY: 3 O RESIDUAL RISK INDEX: 3 ¿ POTENTIAL CAUSES: BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL CAUSE WAS DETERMINED TO BE A CRACKED BARBED FITTING. ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS, AND SERVICEMAX, THE POTENTIAL CAUSE WAS DETERMINED TO BE A CRACKED BARBED FITTING. IN RESPONSE TO THE CUSTOMER REPORTING SEEING CARRYOVER ON THE FACSLYRIC, THE FSE (FIELD SERVICE ENGINEER) WENT ONSITE AND CONFIRMED THE ISSUE BY RUNNING THE SIT FLUSH OPERATION AND SEEING THAT THE SIT (SAMPLE INJECTION TUBE) WAS DRIPPING SHEATH FLUID AND NOT FULLY ASPIRATING THE SAMPLE TO WASTE. UPON OPENING THE SIT DOOR, THE FSE FOUND THAT THE SIT ARM BARBED FITTING WAS BROKEN, THUS CREATING AN AIR LEAK RESULTING IN A SIT FLUSH FAILURE. AFTER REPLACING THE BARB FITTING (PART # 34350807 - BARBED FITT 1/16 ID TUBING SERVICE), THE FSE CHECKED THE INSTRUMENT FOR CARRYOVER BY RUNNING FITC AND PE BEADS AND CONFIRMED THAT THE INSTRUMENT WAS FUNCTIONING AS EXPECTED WITH NO FURTHER CARRYOVER. THIS CASE WAS LINKED TO AN ESCALATION PROJECT, EP-0278 - LYRIC SIT DRIP/CARRYOVER, THAT WAS OPENED TO INVESTIGATE RECURRING ISSUES OF CARRYOVER ON FACSLYRIC INSTRUMENTS TIED TO KINKED PINCH VALVE TUBING. EP-0278 WILL DOCUMENT DETAILS OF THIS INVESTIGATION AND NEXT STEPS TAKEN TO RESOLVE THE ISSUE, AS WELL AS ANY CASES/WORK ORDERS ON THIS ISSUE. HOWEVER, IN THIS COMPLAINT/CASE, THE CARRYOVER WAS CAUSED BY A BROKEN FITTING AND NOT A TUBING ISSUE, AND THE ISSUE WAS RESOLVED BY REPLACING THE FITTING. ALTHOUGH THE INSTRUMENT IS USED TO RUN PATIENT SAMPLES, THIS ISSUE DID NOT PRODUCE ANY ERRONEOUS RESULTS ON PATIENT SAMPLES. THEREFORE, NO PATIENTS WERE DIAGNOSED OR TREATED FROM POTENTIAL INCORRECT RESULTS, AND THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO THE CARRYOVER. NO ONE WAS HARMED OR INJURED DUE TO THIS ISSUE. PROPER DAILY AND MONTHLY CLEANING PROCEDURES CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD FACSLYRIC¿ CLINICAL SYSTEM INSTRUCTIONS FOR USE, #23-19938-04 REV. 01/VERS. A, PAGE 169. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT WAS CONFIRMED AND THE POTENTIAL CAUSE OF THE CUSTOMER SEEING CARRYOVER WAS DETERMINED TO BE A CRACKED BARBED FITTING. THE FSE INVESTIGATED THE ISSUE AND IDENTIFIED THAT THE SIT ARM BARBED FITTING WAS BROKEN, WHICH CREATED AN AIR LEAK RESULTING IN A SIT FLUSH OPERATION FAILURE. AFTER REPLACING THE BARBED FITTING (PART # 34350807) AND TESTING THE INSTRUMENT, THE FSE CONFIRMED THAT THE INSTRUMENT WAS FUNCTIONING AS EXPECTED WITHOUT ANY FURTHER CARRYOVER. NO ERRONEOUS RESULTS WERE PRODUCED ON PATIENT SAMPLES, AND NO ONE WAS HARMED OR INJURED DUE TO THIS ISSUE. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. BASED ON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED BECAUSE THE ISSUE WAS RESOLVED AND THERE WAS NO IMPACT TO CUSTOMER AND PATIENT HEALTH OR SAFETY. ¿ SUPPORTING DOCUMENT: N/A H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WAS A CARRYOVER ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECTION CARRYOVER IS CONTAMINATING THE SAMPLES. CARRY OVER ISSUE.
IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WAS A CARRYOVER ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECTION CARRYOVER IS CONTAMINATING THE SAMPLES. CARRY OVER ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2130250 | BD FACSLYRIC¿ | SEE H.10 | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 662878 | 00382906628787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |