BD FACSLYRIC¿ 3L12C INSTRUMENT
Report
- Report Number
- 2916837-2022-00309
- Event Type
- Malfunction
- Date Received
- October 17, 2022
- Date of Event
- October 10, 2022
- Report Date
- March 13, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- UDI-DI
- 00382906635181
- PMA / PMN Number
- K201814
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L12C INSTRUMENT USIVD, PART # 663518, SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING CARRYOVER THAT OCCURRED ON 10OCT2022. 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 NEITHER THE CUSTOMER NOR ANY PATIENTS WERE HARMED DUE TO THIS ISSUE. MANUFACTURING DEFECT TREND: THERE ARE (B)(4) QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE FOR PART # 663518. DATE RANGE FROM 10OCT2021 TO DATE 10OCT2022. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 663518, SERIAL # (B)(6), FILE # (B)(4) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. COMPLAINT TREND: THERE ARE (B)(4) COMPLAINTS RELATED TO THE ISSUE OF CARRYOVER CAUSED BY A BLOCKAGE FOR PART # 663518; DATE RANGE FROM 10OCT2021 TO DATE 10OCT2022. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION BECAUSE THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. SERVICE HISTORY REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4); CASE #: (B)(4). INSTALL DATE: (B)(6) 2020. DEFECTIVE PART NUMBER(S): 34350807 - BARBED FITT 1/16 ID TUBING SERVICE, 647945 - ORIFICE-RESTRICTOR .020IN DIA BLUE, 336504 - TWO WAY PINCH VALVE ASSEMBLY NC, 654898 - FITTING 1/4-28 TO 1/8 BRB PPL WHITE, 59-10257-00 - CONNECTOR 1/16INX1/16IN ID TUBE, 641925 - PUMP PRIMING P2 MAIN SYSTEM. WORK ORDER NOTES: SUBJECT / REPORTED: CARRY OVER ISSUE. PROBLEM DESCRIPTION: CARRY OVER ISSUE. BD EMPLOYEE (B)(4) SENT FACILITY A CARRY OVER TEST KIT. KIT HAS THREE HIGHS AND THREE LOWS. CUSTOMER IS SEEING GREATER THAN 1% CARRY OVER USING KIT. CUSTOMER IS CURRENTLY VALIDATING INSTRUMENT. NO PATIENTS HAVE BEEN RUN. WORK PERFORMED: INSPECTED PINCH VALVE TUBING, NO LEAKS OR INTERNAL BUILDUP. REPLACED PINCH VALVE TUBING. RED LASER HEIGHT OUT OF SPECIFICATIONS (SPECS ARE 35 +/-1, MEASURED 37.28), ADJUSTED RED LASER HEIGHT TO WITHIN TOLERANCES. PERFORMED ABORT COUNT, RUO CQC, RUO PQC, CLINICAL CQC, AND CLINICAL PQC, NO DISCREPANCIES, UNABLE TO REPLICATE FAILURE. CUSTOMER PERFORMED ASSAY WITH CELLS TO DETERMINE CARRYOVER, RESULTS WERE BETTER BUT STILL NOT WITHIN SPECIFICATIONS. RETURNED ON-SITE. REPLACED P2 PUMP (PN 641925) WITH 2 BARB FITTINGS (PN 654898), FITTING BETWEEN ORANGE AND SILICONE TUBING (PN 59-10257-00), V8 PINCH VALVE (PN 336504), FLOWCELL BLUE RESTRICTOR (PN 647945), AND SIT BLACK FITTING (PN 34350807). PERFORMED SIT FLUSH, REGISTERED 2 DROPS. PERFORMED ABORT COUNT AND PQC, NO DISCREPANCIES. CAUSE: MINOR BLOCKAGE IN WASTE ASSEMBLY. SOLUTION: THE INSTRUMENT IS TESTING WITHOUT ERRORS AND I HAVE RETURNED THE INSTRUMENT TO THE LAB FOR NORMAL USE. 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. HAZARD ID #: LIBIVD-RA-100 3.1.7. HAZARD: INCORRECT OUTPUT FOR SAMPLES UP TO 1.5ML OR LESS. CAUSE: SAMPLE CARRYOVER ERROR - FLUIDIC. HARMFUL EFFECTS: EVENTS APPEAR IN WRONG TUBE (FALSE POSITIVE RESULT). RESIDUAL PROBABILITY: 1. RESIDUAL SEVERITY: 3. RESIDUAL RISK INDEX: 3. POTENTIAL CAUSES: BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL CAUSE WAS DETERMINED TO BE A MINOR BLOCKAGE IN THE WASTE ASSEMBLY. 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 MINOR BLOCKAGE IN THE WASTE ASSEMBLY. DIRT, DEBRIS, OR CLOGS IN THE FLUIDIC SYSTEM WILL CONTRIBUTE TO FLOW RATE AND BACKFLOW ISSUES, ESPECIALLY WITHIN THE SAMPLE OR WASTE LINE. IN RESPONSE TO THE CUSTOMER¿S COMPLAINT REGARDING CARRYOVER, THE FSE(FIELD SERVICE ENGINEER) WENT ONSITE AND CONFIRMED THE ISSUE. TO RESOLVE THE ISSUE, THE FSE INSPECTED AND REPLACED THE PINCH VALVE TUBING AS WELL AS THE P2 PUMP (P/N 641925), V8 PINCH VALVE (P/N 336504), FLOW CELL RESTRICTOR (P/N 647945), AND OTHER FITTINGS (P/N 34350807, 654898, 59-10257-00). AFTER THE REPAIRS, THE INSTRUMENT WAS TESTED AND WAS PERFORMING AS EXPECTED. NO PARTS WERE REQUESTED FOR EVALUATION BECAUSE THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. THE CUSTOMER CONFIRMED THAT THE CARRYOVER DID NOT PRODUCE ERRONEOUS RESULTS ON PATIENT SAMPLES. THEREFORE, NO ONE WAS HARMED OR INJURED DUE TO THIS ISSUE, AND NO PATIENT WAS DIAGNOSED OR TREATED BASED ON THE 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. 01/VERS. A, PAGE 166. 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 EXPERIENCING CARRYOVER ISSUES ON THE FACSLYRIC WAS DETERMINED TO BE A MINOR BLOCKAGE IN THE WASTE ASSEMBLY. THE FSE CONFIRMED THE ISSUE AND PERFORMED A SERIES OF REPLACEMENTS FOR COMPONENTS INCLUDING THE PINCH VALVE V8 AND ITS TUBING, P2 PUMP, FLOW CELL RESTRICTOR, AND VARIOUS FITTINGS. AFTER THESE REPAIRS, THE INSTRUMENT WAS REBOOTED, TESTED, AND FOUND TO BE FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO PATIENT DIAGNOSIS OR TREATMENT WAS PERFORMED BASED ON ANY POTENTIAL ERRONEOUS RESULTS. 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.
IT WAS REPORTED BD FACSLYRIC¿ 3L12C INSTRUMENT CARRY OVER ISSUE OCCURRED. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: "CUSTOMER IS SEEING GREATER THAN 1% CARRY OVER USING KIT. CUSTOMER IS CURRENTLY VALIDATING INSTRUMENT. NO PATIENTS HAVE BEEN RUN."
IT WAS REPORTED BD FACSLYRIC¿ 3L12C INSTRUMENT CARRY OVER ISSUE OCCURRED. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: "CUSTOMER IS SEEING GREATER THAN 1% CARRY OVER USING KIT. CUSTOMER IS CURRENTLY VALIDATING INSTRUMENT. NO PATIENTS HAVE BEEN RUN"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2312566 | BD FACSLYRIC¿ 3L12C INSTRUMENT | FLOW CYTOMETRIC REAGENTS AND ACCESS | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 663518 | 00382906635181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |