BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART
Report
- Report Number
- 2916837-2022-00090
- Event Type
- Malfunction
- Date Received
- April 6, 2022
- Date of Event
- March 29, 2022
- Report Date
- July 15, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- UDI-DI
- 00382903389629
- PMA / PMN Number
- K141468
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
D.1 MEDICAL DEVICE BRAND NAME BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART HAS BEEN CORRECTED.
CHANGED FROM: "COMPLAINT TREND: THERE ARE 24 COMPLAINTS RELATED TO THE ISSUE OF WASTE LEAKAGES NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM 29MAR2021 TO DATE 29MAR2022. ITEM: 9. CHECK VALVE #17. FUNCTION: 9.1 PREVENT BACKFLOW OF CONTAMINANTS INTO SAMPLE. POTENTIAL FAILURE MODE: 9.1.1 SAMPLE "MUSHROOM" FORMS IN FLOW CELL. POTENTIAL EFFECT(S) OF FAILURE: 9.1.1.1 NOISE, WRONG RESULTS, UNWANTED EVENTS IN GATE POTENTIAL CAUSE(S)/MECHANISM(S) OF FAILURE: 9.1.1.1.1 TUBE NOT REMOVED, CAUSING BACKPRESSURE. CURRENT CONTROLS: USER EXAMINES DOT PLOTS. RECOMMENDED ACTIONS: LEAVE FLUIDICS RUNNING AT LOW FLOW RATE. ACTIONS TAKEN: COMPLETE: CLEAR CASE ENTRY 10/23/03 ((B)(6)), CO# (B)(4) (FACSDIVA 4.0). SEVERITY 5. OCCURRENCE: 7. DETECTION: 2. RPN: 70". CHANGED TO: ¿COMPLAINT TREND: THERE ARE 23 COMPLAINTS RELATED TO THE ISSUE OF WASTE LEAKAGES NOT CONTAINED WITHIN THE INSTRUMENT. THESE COMPLAINTS CAN BE FOUND IN THE ATTACHED COMPLAINT TREND FILE. DATE RANGE FROM 29MAR2021 TO DATE 29MAR2022. ITEM 9 UNDER HAZARD SEEMS TO BE INAPPROPRIATE CONSIDERING ITEM 23 SO HAZARD ITEM 9 REMOVED FROM THE INVESTIGATION SUMMARY - RISK ANALYSIS HAZARD ID".
H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACSCANTO II CYTOMETER 4/2/2 SYS IVD, PART # 338962, SERIAL # (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING A BIOHAZARD LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT. ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 29MAR2021 TO DATE 29MAR2022. ¿ COMPLAINT TREND: THERE ARE 24 COMPLAINTS RELATED TO THE ISSUE OF WASTE LEAKAGES NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM 29MAR2021 TO DATE 29MAR2022. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 338962 SERIAL # (B)(6), FILE # 338963-V96300884-900218029-09 / 338962-V96300884-900218027-09, 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 NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN CHECK VALVE. THE CUSTOMER REPORTED THAT THERE WAS A LEAKAGE FROM UNDER THE WETCART AND AN FSE WAS SENT ONSITE FOR THE REPAIR. THE FSE CONFIRMED THE ISSUE AND REPLACED THE WORN CHECK VALVE FROM THE WETCART. AFTER THE REPLACEMENT OF THE PART, THE INSTRUMENT WAS TESTED AND CONFIRMED TO BE FUNCTIONING AS EXPECTED WITH NO FURTHER LEAKAGES. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. ALTHOUGH THE LEAKAGE WAS OF A BIOHAZARDOUS MATERIAL, THE CUSTOMER CONFIRMED THAT THEY DID NOT COME IN CONTACT WITH THE LEAKAGE AND WERE NOT HARMED IN ANY WAY. ADDITIONALLY, THE LEAKAGE WAS NOT UNDER PRESSURE AND THUS DID NOT INCREASE THE RISK OF EXPOSURE. PROPER DAILY AND MONTHLY CLEANING AND MAINTENANCE CAN HELP IN PREVENTING LOWERED PERFORMANCE OF THE SYSTEM, AND CAN BE FOUND IN THE BD FACSCANTO II INSTRUCTIONS FOR USE (IFU), #23-20269-00 REV. 1/VERS. A. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 02390840, CASE # (B)(4). INSTALL DATE: 01DEC2009. DEFECTIVE PART NUMBER: 334044 ¿ CHECK VALVE WASTE. WORK ORDER NOTES: O SUBJECT / REPORTED: FLUID UNDER THE WETCART. O PROBLEM DESCRIPTION: FLUID UNDER THE WETCART. O WORK PERFORMED: CUSTOMER VISIT FROM: 29.03.2022. A BROKEN COMPONENT IN THE FLUID PATH ON YOUR FACSCANTO WETCART HAS BEEN FOUND TO BE THE SOURCE OF THE LEAK. THE REPLACEMENT OF A NON-RETURN PN 334044 IN THE WETCART SOLVED THE MALFUNCTION. FINAL TEST: - STARTUP EFFECT SUCCESSFULLY. - PERFORMANCE CHECK COMPLETED SUCCESSFULLY. THE INSTRUMENT OPERATES WITHIN INSTRUMENT SPECIFICATIONS AND IS READY FOR ROUTINE USE WITHOUT RESTRICTIONS. O CAUSE: ANTI-REVERSE PN 334044 BROKEN. O SOLUTION: REPLACEMENT OF THE NON-RETURN PN 334044. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART #338960-04RA, REV. 01/VERS. A, RISK ANALYSIS CANTO II FLUIDICS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES OR NO? O ITEM: 9. CHECK VALVE #17. O FUNCTION: 9.1 PREVENT BACKFLOW OF CONTAMINANTS INTO SAMPLE. O POTENTIAL FAILURE MODE: 9.1.1 SAMPLE "MUSHROOM" FORMS IN FLOW CELL. O POTENTIAL EFFECT(S) OF FAILURE: 9.1.1.1 NOISE, WRONG RESULTS, UNWANTED EVENTS IN GATE. O POTENTIAL CAUSE(S)/MECHANISM(S) OF FAILURE: 9.1.1.1.1 TUBE NOT REMOVED, CAUSING BACKPRESSURE. O CURRENT CONTROLS: USER EXAMINES DOT PLOTS. O RECOMMENDED ACTIONS: LEAVE FLUIDICS RUNNING AT LOW FLOW RATE. O ACTIONS TAKEN: COMPLETE: CLEAR CASE ENTRY 10/23/03 (DAVID VRANE), CO#46339 (FACSDIVA 4.0). O SEVERITY 5. O OCCURRENCE: 7. O DETECTION: 2. O RPN: 70. O ITEM: 23. VALVES. O FUNCTION: 23.1 BLOCK, PASS, OR DIRECT FLUIDS. O POTENTIAL FAILURE MODE: 23.1.1 VALVE LEAKS. O POTENTIAL EFFECT(S) OF FAILURE: 23.1.1.1 FLUIDICS MODE OPERATES INCORRECTLY, DEGRADATION OF PERFORMANCE. O POTENTIAL CAUSE(S)/MECHANISM(S) OF FAILURE: 23.1.1.1.1 STUCK VALVE OR DEBRIS OR SALINE BUILDUP. O CURRENT CONTROLS: DI RINSE DAILY. O RECOMMENDED ACTIONS: N/A. O ACTIONS TAKEN: N/A. O SEVERITY 5. O OCCURRENCE: 7. O DETECTION: 1. O RPN: 35. MITIGATION(S) SUFFICIENT: YES OR NO? ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN CHECK VALVE. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN CHECK VALVE. THE FSE CONFIRMED THE ISSUE AND REPLACED THE WORN CHECK VALVE. AFTER THE REPAIR, AN INSTRUMENT STARTUP AND CHECK PERFORMANCE TEST WAS COMPLETED AND THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL TREATMENT WAS PERFORMED DUE TO THE BIOHAZARDOUS LEAK. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL.
IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 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. CLAUDIA BRAUN : 2022-03-29 09:15:53 (GMT) FLUID UNDER THE WETCART"
IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 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. FLUID UNDER THE WETCART."
IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 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. (B)(4). FLUID UNDER THE WETCART".
IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 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. CLAUDIA BRAUN : 2022-03-29 09:15:53 (GMT). FLUID UNDER THE WETCART."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1899875 | BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART | COUNTER, DIFFERENTIAL CELL | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 338962 | NA | 00382903389629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |