BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO¿ II

    MDR report key: 12044545 · Received June 22, 2021

    Report

    Report Number
    2916837-2021-00285
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    October 14, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACSCANTO II CYTOMETER 4/2/2 SYS IVD, PART # 338962 AND SERIAL # (B)(6) . PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON A LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGES FROM (B)(6) 2020 TO DATE (B)(6) 2021. COMPLAINT TREND: THERE ARE 16 COMPLAINTS RELATED TO THE ISSUE OF A LEAKAGE FROM THE SIT NOT CONTAINED WITHIN INSTRUMENT; DATE RANGES FROM (B)(6) 2020 TO DATE (B)(6) 2021. 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 LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOG IN ONE OF THE WASTE LINES. THE CUSTOMER HAD REPORTED THAT AFTER A SIT FLUSH, THE LIQUID IN THE ASPIRATOR ARM WOULD NOT BE ASPIRATED AWAY. DURING THE PHONE CONSULTATION, THE TSR (TECHNICAL SERVICE REPRESENTATIVE) SUGGESTED THAT THE CUSTOMER FLUSH THE ARM APERTURE WITH HOT WATER AND MASSAGE THE V19 TUBING. THESE REPAIRS DID NOT SOLVE THE ISSUE, SO THEY THEN RECOMMENDED A LONG CLEAN AND TO FLUSH THE V19 LINE. THE CUSTOMER LATER REPORTED THAT THEY HAD PERFORMED THE FLUSH OF THE V19 TUBING AND THIS SOLVED THE ISSUE. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. AFTER THE CLEANING, THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS FUNCTIONING AS EXPECTED WITH NO FURTHER LEAKAGES. CLOGS IN THE SYSTEM CAN CONTRIBUTE TO VARIOUS RISKS INCLUDING CONTAMINATION OF SAMPLES, ERRONEOUS RESULTS, FLOW RATE ISSUES, AND LEAKS WITHIN AND OUTSIDE OF THE INSTRUMENT. PATIENT SAMPLES WERE USED IN THIS INCIDENT BUT THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSIS DECISION AND DID NOT AFFECT THE PATIENT. WHILE THE LEAKED FLUID WAS WASTE WHICH MAY POSE A RISK OF CONTAMINATION, THE CUSTOMER DID NOT COME IN CONTACT WITH THE LEAK AND WAS NOT HARMED. ADDITIONALLY, THERE WAS NO SPRAY OF FLUID DURING THIS INCIDENT AND THUS THE LEAKAGE DID NOT SIGNIFICANTLY INCREASE THE RISK OF EXPOSURE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4), CASE # (B)(4). INSTALL DATE: (B)(6) 2013. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: O SUBJECT / REPORTED: 338962 - BD FACSCANTO II - SIT FLUSH ISSUE. O PROBLEM DESCRIPTION: WHEN PERFORMING A SIT FLUSH, THE LIQUID IS NOT ASPIRATED BY THE ASPIRATOR ARM. O WORK PERFORMED: (B)(6), (B)(6) 2021 14:22:13Z: FURTHER ACTION, HELPDESK-AWAIT CUSTOMER RESPONSE. FLUSHING WITH HOT DI WATER IN THE ARM APERTURE DID NOT HELP. CUSTOMER HAS TAKEN OFF THE TUBING OF V19 AND MASSAGE IT BUT ISSUE PERSISTS. SUGGESTED LONG CLEAN AND WASTE LINE FLUSH FROM V19. O CAUSE: CLOG. O SOLUTION: INSTRUMENT FUNCTIONAL. INTERNAL NOTES: O FLUSHING V19 LINE SOLVED THE ISSUE. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO REPLACED PARTS. 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 MITIGATION IS SUFFICIENT. THE SEVERITY RATING IN THIS FILE IS ¿9¿ AND HAS AN RPN OF ¿90¿ BASED ON THE PREVIOUS SCALE RATING. THIS RATING IS EQUIVALENT TO ¿S3¿ IN SOP6078-02 REV. 12/VERS. J, WHEREBY THERE IS POTENTIAL FOR MINOR NON-PERMANENT INJURY SHOULD THERE BE CONTACT WITH THE LEAKED MATERIAL, THOUGH THE ISSUE WAS EASILY AND QUICKLY IDENTIFIED. THE CURRENT MITIGATIONS ARE ADEQUATE WITH RPN UNDER ACCEPTABLE RANGE. HAZARD(S) IDENTIFIED? YES, NO. ITEM: 7 1/8" - 1/16" FLUIDICS COUPLING. FUNCTION: 7.1 CONNECT 1/8" ID TRAP TUBING TO 1/16" PINCH VALVE TUBING . POTENTIAL FAILURE MODE: 7.1.1 CLOGS WITH SALT CRYSTALS . POTENTIAL EFFECT(S) OF FAILURE: 7.1.1.1 BIOHAZARD EXPOSURE . POTENTIAL CAUSE(S)/MECHANISM(S) OF FAILURE: 7.1.1.1.1 WASTE TRAP OVERFLOWS, LEAKS THROUGH BYPASS (BIOHAZARD) . CURRENT CONTROLS: AUTOMATIC SHUTDOWN OF FLUIDICS, WITH DI RINSE . RECOMMENDED ACTIONS: 1. ELIMINATE REDUCER. 2. INCORPORATE LEVEL SENSOR IN WASTE BUFFER TANK. 3. INCREASE DI CYCLE RINSE TIME . SEVERITY: 9 . OCCURRENCE: 2 . DETECTION: 5 . RPN: 90 . MITIGATION(S) SUFFICIENT YES, NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOG IN ONE OF THE WASTE LINES. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOG IN ONE OF THE WASTE LINES. DURING A REMOTE ASSISTANCE, THE TSR CONFIRMED THE ISSUE AND INSTRUCTED THE CUSTOMER TO PERFORM SEVERAL CLEANINGS OF THE INSTRUMENT TO CLEAR THE CLOG. FLUSHING THE ARM APERTURE WITH HOT WATER AND MASSAGING THE V19 TUBE DID NOT WORK, SO THEY SUGGESTED A LONG CLEAN AND FLUSHING THE V19 LINE. LATER ON, THE CUSTOMER CONFIRMED THAT FLUSHING THE V19 LINE CLEARED THE CLOG AND THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE LEAKAGE. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACSCANTO¿ II BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PERFORMING A SIT FLUSH, THE LIQUID IS NOT ASPIRATED BY THE ASPIRATOR ARM. 1. IS THE LEAK FLUID OR AIR? FLUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 3. WAS THE FLUID SPRAYING UNDER PRESSURE? NO. 4. IS LEAKED LIQUID TYPE KNOWN? BIOHAZARDOUS OR NON-BIOHAZARDOUS? THE LIQUID WAS FACSFLOW (SALINE SOLUTION). IT WAS IN CONTACT WITH THE SAMPLE INJECTION TUBE OF THE INSTRUMENT HOWEVER, SO MUST BE CONSIDERED BIOHAZARDOUS. 5. DID THE LEAKED LIQUID HAVE BLEACH MIXED IN? NO. 6. WAS ANYONE INJURED DUE TO THE LEAKED LIQUID? NO, NO-ONE CAME IN CONTACT WITH THE LEAKED FLUID.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 · 1

    IT WAS REPORTED WHILE USING BD FACSCANTO¿ II BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PERFORMING A SIT FLUSH, THE LIQUID IS NOT ASPIRATED BY THE ASPIRATOR ARM. IS THE LEAK FLUID OR AIR? FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE FLUID SPRAYING UNDER PRESSURE? NO. IS LEAKED LIQUID TYPE KNOWN? BIOHAZARDOUS OR NON-BIOHAZARDOUS? THE LIQUID WAS FACSFLOW (SALINE SOLUTION). IT WAS IN CONTACT WITH THE SAMPLE INJECTION TUBE OF THE INSTRUMENT HOWEVER, SO MUST BE CONSIDERED BIOHAZARDOUS. DID THE LEAKED LIQUID HAVE BLEACH MIXED IN? NO. WAS ANYONE INJURED DUE TO THE LEAKED LIQUID? NO, NO-ONE CAME IN CONTACT WITH THE LEAKED FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941870 BD FACSCANTO¿ II COUNTER, DIFFERENTIAL CELL OYE 338962 NA 00382903389629

    Patients

    Seq Age Sex Outcome Treatment
    1