BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO¿ II

    MDR report key: 14876971 · Received June 30, 2022

    Report

    Report Number
    2916837-2022-00165
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 6, 2022
    Report Date
    October 11, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WAS THE LEAK FLUID OR AIR? (IF FLUID, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.)LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.) NOT CONTAINED. WAS THERE SPRAY OF FLUID UNDER PRESSURE? (IF YES DESCRIBE THE FLUID THAT SPRAYED THEN GO TO QUESTION #7, IF NO, GO TO QUESTION #4) NO. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD, GO TO QUESTION #5) BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6) AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAMINATION, NO FURTHER QUESTIONS REQUIRED.) NO. " WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO CONTACT, NO FURTHER QUESTIONS REQUIRED.) NO. PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN.". WASTE PROBE IS DEFECTIVE" H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CORRECTION MADE TO CAPTURE SUMMARY. INVESTIGATION SUMMARY: ¿ 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 DUE TO A DEFECTIVE WASTE PROBE. ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 06JUN2021 TO DATE 06JUN202022. ¿ COMPLAINT TREND: THERE ARE 6 COMPLAINTS RELATED TO THE ISSUE OF A LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT DUE TO A CABLE, WIRE, FITTING, AND/OR CONNECTOR. . DATE RANGE FROM 06JUN2021 TO DATE 06JUN2022. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 338962 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 THE BIOHAZARD LEAK NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO WORN WASTE FITTING FIXTURES. THE CUSTOMER HAD INITIALLY REPORTED THAT THEIR INSTRUMENT¿S WASTE PROBE WAS DEFECTIVE, BUT LATER CORRECTED THEMSELVES AND STATED THAT THE ISSUE WAS ACTUALLY A LEAKAGE FROM A WETCART WASTE TUBING FITTING. DURING THE INITIAL REMOTE ASSISTANCE, THE TSR (TECHNICAL SERVICE REPRESENTATIVE) RECOMMENDED THAT TWO PANEL MOUNTS BE REPLACED (33697807 PANEL MOUNT 1/4, FLOW, ORANGE, 59-10181-05 PANEL MOUNT 1/8, ORANGE) AND AN FSE (FIELD SERVICE ENGINEER) WAS SENT ONSITE FOR A FIELD SERVICE. UPON THEIR ARRIVAL, THE FSE CONFIRMED THE WASTE LEAKAGE AND REPLACED THE TWO PANEL MOUNTS. AFTER THE REPLACEMENT, THE LEAKAGE WAS CONFIRMED TO HAVE BEEN RESOLVED. BEFORE THE REPAIR WAS COMPLETED, THE FSE DISCOVERED THAT THE EVENT RATE WAS LOW IN THE CST AND RESOLVED IT IN COMPLAINT PR #5362920. AFTER THE REPAIRS, THE INSTRUMENT WAS PERFORMING AS EXPECTED WITH NO FURTHER LEAKS. THE REPLACED PARTS WERE NOT REQUESTED FOR EVALUATION AS THEY ARE NOT RETURNABLE AND WERE DISCARDED. ALTHOUGH THE LEAK WAS WASTE AND THE POTENTIAL EXPOSURE TO BIOHAZARD MATERIAL, THERE WAS NO SKIN CONTACT NOR WAS THERE ANY MEDICAL TREATMENT PERFORMED. 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 MAINTAIN AN OPTIMAL SYSTEM, AND INSTRUCTIONS 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 #: (B)(4), CASE # (B)(4), INSTALL DATE: 27SEP2011. DEFECTIVE PART NUMBER: 34352807, 59-10181-05, WORK ORDER NOTES: SUBJECT / REPORTED: 338962 - BD FACSCANTO II CYTOMETER 4/2/2 SYS IVD - WASTE PROBE IS DEFECTIVE PROBLEM DESCRIPTION: WASTE PROBE IS DEFECTIVE WORK PERFORMED: BH 9/6/2022 CONFIRMED LEAK ON WASTE CONNECTOR WITH USER VIJAY. REPLACED MALE & FEMALE FIXTURE FROM GREY STOCK. PN#34352807 PN#59-10181-05. STARTED, CHECKED VISUALLY NO LIQUID LEAK FROM AREA. CST RUN BY USER - FAILED. DUE TO TOO LOW EVENT RATE ON LOW FLOW. SEPARATE CASE OPENED FOR ADDITIONAL FAULT. WO-02490517. CST RUN AGAIN POST RESOLUTION OF LOW FLOW RATE AND CST PASSED. HANDED BACK TO USER. CAUSE: WEAR AND TEAR OF FIXTURE ON THE WASTE CONNECTOR FROM WET ART TO THE CONTAINER. SOLUTION: REPLACED THE MALE & FEMALE FIXTURE. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART #338960-04RA, REV. 01/VERS. A, BD FACSCANTO II FLOW CYTOMETER (FLUIDICS) FMEA WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES/ NO. ITEM: 4. QUICK DISCONNECT. FUNCTION: 4.1 CONNECTS TUBING TO FILTERS AND FLUID TANKS. POTENTIAL FAILURE MODE: 4.1.1 TUBING FAILURE. POTENTIAL EFFECT(S) OF FAILURE: 4.1.1.1 LEAKS AT WASTE TANK. BIOHAZARD. POTENTIAL CAUSE(S)/MECHANISM(S) OF FAILURE: WASTE FITTING LEAKS CURRENT CONTROLS: 1. PUMP COMPENSATES FOR LEAKING. RECOMMENDED ACTIONS: N/A. RESPONSIBLE PARTY: N/A. TARGET COMPLETION DATE: N/A. ACTIONS TAKEN: N/A. INITIAL SEVERITY: 9. INITIAL OCCURRENCE: 6. INITIAL DETECTION: 1. RPN: 54. MITIGATION(S) SUFFICIENT: YES/ NO. ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO WORN WASTE CONNECTOR FIXTURES. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO WORN WASTE CONNECTOR FIXTURES. THE CUSTOMER HAD INITIALLY REPORTED THAT THEY OBSERVED A DEFECTIVE WASTE PROBE, BUT LATER CORRECTED THEMSELVES AND CLARIFIED THAT THE ISSUE WAS A WASTE LEAKAGE FROM THE WETCART WASTE TUBING FITTING. DURING INITIAL CONTACT, THE TSR SUGGESTED REPLACING TWO PANEL MOUNTS (PN 33697807, 59-10181-05). DURING THE FIELD SERVICE, THE FSE CONFIRMED THE WASTE LEAKAGE AND REPLACED THE MALE AND FEMALE FIXTURES FROM GREY STOCK (PN 34352807, 59-10181-05) AND CONFIRMED THAT THE LEAKAGE HAD BEEN FIXED. AFTER ALL THE REPAIRS, 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. ¿ SUPPORTING DOCUMENT: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. WAS THE LEAK FLUID OR AIR? (IF FLUID, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.) LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.) NOT CONTAINED. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? (IF YES DESCRIBE THE FLUID THAT SPRAYED THEN GO TO QUESTION #7, IF NO, GO TO QUESTION #4) NO. 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD, GO TO QUESTION #5) BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6) AFTER WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAMINATION, NO FURTHER QUESTIONS REQUIRED.) NO. "7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO CONTACT, NO FURTHER QUESTIONS REQUIRED.) NO. PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN." WASTE PROBE IS DEFECTIVE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WAS THE LEAK FLUID OR AIR? (IF FLUID, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.)LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.) NOT CONTAINED. WAS THERE SPRAY OF FLUID UNDER PRESSURE? (IF YES DESCRIBE THE FLUID THAT SPRAYED THEN GO TO QUESTION #7, IF NO, GO TO QUESTION #4) NO. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD, GO TO QUESTION #5) BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE, GO TO QUESTION # IF AFTER WASTE LINE, GO TO QUESTION #6) AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAMINATION, NO FURTHER QUESTIONS REQUIRED.) NO. "WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO CONTACT, NO FURTHER QUESTIONS REQUIRED.) NO. PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN.". WASTE PROBE IS DEFECTIVE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. WAS THE LEAK FLUID OR AIR? (IF FLUID, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.) LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.) NOT CONTAINED. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? (IF YES DESCRIBE THE FLUID THAT SPRAYED THEN GO TO QUESTION #7, IF NO, GO TO QUESTION #4) NO. 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD, GO TO QUESTION #5) BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6) AFTER WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAMINATION, NO FURTHER QUESTIONS REQUIRED.) NO. "7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO CONTACT, NO FURTHER QUESTIONS REQUIRED.) NO. PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN." WASTE PROBE IS DEFECTIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007336 BD FACSCANTO¿ II COUNTER, DIFFERENTIAL CELL OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 338962 NA 00382903389629

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown