BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD

    MDR report key: 12700216 · Received October 26, 2021

    Report

    Report Number
    2916837-2021-00415
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 29, 2021
    Report Date
    March 28, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903389605
    PMA / PMN Number
    K062087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD, PART # 338960 AND SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING AN ABNORMAL SSC SIGNAL PRODUCING ERRONEOUS RESULTS. MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 29SEP2020 TO DATE 29SEP2021. COMPLAINT TREND: THERE ARE (B)(4) COMPLAINTS RELATED TO THE ISSUE OF ABNORMAL SIGNAL; DATE RANGE FROM 29SEP2020 TO DATE 29SEP2021. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 338960 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 ERRONEOUS RESULTS WAS DUE TO ABNORMAL FLUID FLOW RATES. THE CUSTOMER REPORTED THAT THE SSC SIGNALS WERE ABNORMAL AND REQUESTED FOR A FIELD SERVICE. ACCORDING TO TASK 4160475 IN TRACKWISE, THE FSE CONFIRMED THE ISSUE AND REPLACED THE WASTE BUFFER BOTTLE (PN 344330), FLUIDICS MANIFOLD (PN 642137), AND THE LOADER DRAWER BAYONET(PN 642863). THEY THEN ADJUSTED THE DRAWER POSITION AND SET THE SHEATH FLUID PRESSURE. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. AFTER THE REPAIR THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS BEING USED FOR CLINICAL DIAGNOSES, THE RESULTS GATHERED DURING THE INCIDENT WERE NOT USED AND NO PATIENT SAMPLES WERE AFFECTED. THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSIS DECISION AND WAS REPORTED TO BD AS NOT EXPECTED. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. 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: (B)(6) 2014. DEFECTIVE PART NUMBER: 344330 - WASTE BUFFER TANK W/LEVEL SENSOR; 642137 - ASSEMBLY CANTO II 8-VALVE MANIFOLD; 642863 - PLUNGER SPR 1/4-20 1-3.5LB LOCK. WORK ORDER NOTES: SUBJECT / REPORTED: PI-338960-FACSCANTO II-SSC SIGNAL RESULT IS ABNORMAL. PROBLEM DESCRIPTION: FACSCANTO II SSC SIGNAL RESULTS ARE ABNORMAL. USE OF CLINICAL SAMPLES DOES NOT AFFECT PATIENT TREATMENT. THE FAILURE REAPPEARS, I HOPE THE ENGINEER WILL COME TO THE DOOR AS SOON AS POSSIBLE. WORK PERFORMED: REPLACE ONE SET OF FLOW CHAMBER, ONE SET OF VALVE GROUP, 488NM BLUE OPTICAL FIBER, WASTE BUFFER BOTTLE, LOADER DRAWER BAYONET, SET THE SHEATH FLUID PRESSURE TO 3.6PSI, CHECK THE SIGNAL, CORRECT THE OPTICAL PATH, ADJUST THE DRAWER POSITION, AND PASS THE CST CALIBRATION. CAUSE: THE SSC SIGNAL OBTAINED BY LOADING THE SAMPLE IS ABNORMAL, AND IT STABILIZES AFTER DRIFTING DOWNWARD FROM THE NORMAL POSITION AFTER ABOUT 10 SECONDS. SOLUTION: REPLACE ONE SET OF FLOW CHAMBER, ONE SET OF VALVE GROUP, 488NM BLUE OPTICAL FIBER, WASTE BUFFER BOTTLE, LOADER DRAWER BAYONET, SET THE SHEATH FLUID PRESSURE TO 3.6PSI, CHECK THE SIGNAL, CORRECT THE OPTICAL PATH, ADJUST THE DRAWER POSITION, AND PASS THE CST CALIBRATION. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. RISK ANALYSIS: RISK MANAGEMENT FILE FACSCANTO II FLOW CYTOMETER (FLUIDICS) #338960-04RA (VERSION A/REVISION 1) WAS REVIEWED AND IDENTIFIED THE CAUSE OF FLUID FLOW ISSUES. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES NO. ITEM: FLOW CELL VALVE. FUNCTION: CONTROLS SHEATH TO FLOW CELL. POTENTIAL FAILURE MODE: SHEATH NOT SUPPLIED TO FLOW CELL. POTENTIAL EFFECTS OF FAILURE: 1.1.2.8. VALVE STUCK CLOSED ¿ NO EVENTS. LOSS OF SAMPLE. POTENTIAL CAUSES/MECHANISMS OF FAILURE: MECHANICAL FAILURE - VALVE STUCK CLOSED. CURRENT CONTROLS: CLEAN CYCLE. RECOMMENDED ACTIONS: SWITCH PINCH VALVES TO MANIFOLD ISOLATION VALVES. SEV: 5. OCC: 2. DET: 1. RPN: 10. ITEM: 23. VALVES. FUNCTION: 23.1 BLOCK, PASS, OR DIRECT FLUIDS. POTENTIAL FAILURE MODE: 23.1.2 VALVE CLOGS. POTENTIAL EFFECTS OF FAILURE: 23.1.2.1 FLUIDICS MODE OPERATES INCORRECTLY, DEGRADATION OF PERFORMANCE. POTENTIAL CAUSES/MECHANISMS OF FAILURE: 23.1.1.1.1 STUCK VALVE OR DEBRIS OR SALINE BUILDUP CURRENT CONTROLS: DI RINSE DAILY. RECOMMENDED ACTIONS: SWITCH PINCH VALVES TO MANIFOLD ISOLATION VALVES. SEV: 5. OCC: 7. DET: 1. RPN: 35. MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE ERRONEOUS RESULTS WAS DUE TO FLUID FLOW ISSUES FROM THE FLUIDICS MANIFOLD. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE ERRONEOUS RESULTS WAS DUE TO FLUID FLOW ISSUES FROM THE FLUIDICS MANIFOLD. THE FSE REPLACED THE FLUIDICS MANIFOLD, LOADER DRAWER BAYONET, AND WASTE BUFFER BOTTLE. THEY THEN ADJUSTED THE DRAWER POSITION, SET THE SHEATH FLUID PRESSURE, AND TESTED THE INSTRUMENT. AFTER THE REPAIRS THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. NO TREATMENT OR DIAGNOSIS WAS GIVEN DUE TO THE UNEXPECTED RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WHILE USING BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD/ASR REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. WERE THE SAMPLES ANALYZED ON THE INSTRUMENT PATIENT SAMPLES? NO. IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? NO. ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? NO. WAS THERE ANY HARM TO THE PATIENT? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WHILE USING BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD/ASR REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. WERE THE SAMPLES ANALYZED ON THE INSTRUMENT PATIENT SAMPLES? NO. IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? NO. ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? NO. WAS THERE ANY HARM TO THE PATIENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593778 BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 338960 NA 00382903389605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown