BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD

    MDR report key: 12468293 · Received September 14, 2021

    Report

    Report Number
    2916837-2021-00371
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    June 21, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903429752
    PMA / PMN Number
    K923790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD, PART #342975, SERIAL # (B)(6) . PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT OF A LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 21MAY2020 TO 21MAY2021. COMPLAINT TREND: THERE ARE 9 COMPLAINTS RELATED TO THE ISSUE OF A LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM 21MAY2020 TO 21MAY2021. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #342975, 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 WORN CONNECTORS. AFTER THE CUSTOMER SUBMITTED THE COMPLAINT A TSR (TECHNICAL SERVICE REPRESENTATIVE) ATTEMPTED TO ASSIST THE CUSTOMER, BUT WERE NOT ABLE TO EFFECTIVELY HELP REMOTELY AND THEY SCHEDULED A FIELD SERVICE. THE FSE (FIELD SERVICE ENGINEER) THAT CAME ONSITE DISCOVERED THAT THE LEAKAGE WAS DUE TO WORN CONNECTORS AND TUBINGS, AND REPLACED THE PARTS. NO PARTS WERE REQUESTED FOR EVALUATION AS THEY ARE NOT PART OF STOCK INVENTORY AND WERE DISCARDED. THE FSE THEN CHECKED THE DC VOLTAGE, LASER POWER, HYDRAULIC PRESSURE, AND 2/6U MICROSPHERE PRESSURE BEFORE ALIGNING THE OPTICAL PATH. AFTER THE REPAIR THE INSTRUMENT WAS FUNCTIONING AS EXPECTED WITH NO FURTHER LEAKAGES. ALTHOUGH THE LEAK WAS LISTED AS NON-BIOHAZARD BY THE CUSTOMER, THE FSE CONFIRMED IN (B)(4) ¿WFI-WO-SAFETY ALIGNMENT¿ THAT THE LEAKAGE WAS BIOHAZARD. THE LEAKAGE WAS NOT UNDER PRESSURE AND THUS DID NOT SIGNIFICANTLY INCREASE THE RISK OF EXPOSURE. ADDITIONALLY, NO USER WAS HARMED OR INJURED AS THEY DID NOT COME IN CONTACT WITH THE LEAKAGE. THIS INSTRUMENT WAS BEING USED FOR RESEARCH PURPOSES SO NO PATIENTS WERE HARMED DUE TO ANY RESULTS GATHERED DURING THE INCIDENT. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4), CASE # (B)(4). INSTALL DATE: (B)(6) 2003. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES:. SUBJECT / REPORTED: PI-342975-FACSCALIBUR-LEAKING. PROBLEM DESCRIPTION: 1. FACSCALIBUR LEAKAGE. 2. THE LEAKED LIQUID IS SHEATH LIQUID, NO ONE HAS CONTACT WITH IT, NO ONE HAS CAUSED INJURY. 3. FOR SCIENTIFIC RESEARCH, THE QUOTATION HAS BEEN STAMPED AND SENT BACK. WORK PERFORMED: RESOLVE AFTER REPLACING THE LEAKING JOINTS AND PIPELINES. REPAIR THE INSTRUMENT: THE DC VOLTAGE IS NORMAL, THE LASER POWER IS NORMAL, THE HYDRAULIC PRESSURE IS NORMAL, THE SIGNAL OF THE 2/6U MICROSPHERE IS GOOD AFTER FINE-TUNING THE OPTICAL PATH, AND THE INSTRUMENT IS OPERATING NORMALLY CAUSE: RESOLVE AFTER REPLACING THE LEAKING JOINTS AND PIPELINES. REPAIR THE INSTRUMENT: THE DC VOLTAGE IS NORMAL, THE LASER POWER IS NORMAL, THE HYDRAULIC PRESSURE IS NORMAL, THE SIGNAL OF THE 2/6U MICROSPHERE IS GOOD AFTER FINE-TUNING THE OPTICAL PATH, AND THE INSTRUMENT IS OPERATING NORMALLY SOLUTION: RESOLVE AFTER REPLACING THE LEAKING JOINTS AND PIPELINES. REPAIR THE INSTRUMENT: THE DC VOLTAGE IS NORMAL, THE LASER POWER IS NORMAL, THE HYDRAULIC PRESSURE IS NORMAL, THE SIGNAL OF THE 2/6U MICROSPHERE IS GOOD AFTER FINE-TUNING THE OPTICAL PATH, AND THE INSTRUMENT IS OPERATING NORMALLY 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 # 342973-01RA, REV. 01/VERS. A, BD FACSCALIBUR FAILURE MODE AND EFFECT ANALYSIS WAS REVIEWED. THE SEVERITY RATING IN THIS FILE IS ¿5¿ BASED ON THE PREVIOUS SCALE RATING. THIS RATING IS EQUIVALENT TO ¿S2¿ IN SOP6078-02 REV. 12/VERS. J, WHEREBY A WASTE LEAK IS OBVIOUS OR INDICATED BY ADDITIONAL (WARNING) INFORMATION AND HENCE THE IMPACT TO THE PATIENT IS NEGLIGIBLE TO NONE. THE CURRENT MITIGATIONS ARE ADEQUATE WITH RPN UNDER ACCEPTABLE RANGE. HAZARD(S) IDENTIFIED? YES NO. ITEM: DROPLET CONTAINMENT MODULE. FUNCTION: TO CONTAIN DROPLETS. POTENTIAL FAILURE MODE: DROPLETS NOT CONTAINED. POTENTIAL EFFECTS OF FAILURE: ALL OF THE SAMPLE IS. POTENTIAL CAUSES/MECHANISMS OF FAILURE: PUMP NOT PROPERLY SEALED. CURRENT CONTROLS: N/A. RECOMMENDED ACTIONS: N/A. RESPONSIBLE PARTY: N/A. TARGET COMPLETION DATE: N/A. ACTIONS TAKEN: N/A. SEV: 5. OCC: 5. DET: 1. RPN: 25. MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE WAS DUE TO WORN CONNECTORS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE WAS DUE TO WORN CONNECTORS. THE FSE IDENTIFIED THE ISSUE AND REPLACED THE LEAKING CONNECTORS AND PIPES. THEY THEN VERIFIED THAT THE DC VOLTAGE, LASER POWER, HYDRAULIC PRESSURE, AND SIGNAL OF THE 2/6U MICROSPHERE WAS NORMAL. FINALLY, THE FSE ALIGNED THE OPTICAL PATH AND THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO FURTHER LEAKS OCCURRED. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SUSPECT THE LEAKAGE WAS SHEATH FLUID, SO THE CHECKLIST WAS NON BIOHAZARD. BUT AFTER FSE ON SITE FOUND THE LEAKAGE WAS WASTE FLUID. SO THE EVENT DESCRIPTION WAS BIOHAZARD. ADDITIONAL INFORMATION: ACCORDING TO THE NOTE OF CASE IN THE SMAX. THE LEAKED LIQUID IS WASTE LIQUID. 1. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, 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 LIQUID UNDER PRESSURE? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): NO. 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. 5 DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): UNKNOWN. 7 WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO. 1. FACSCALIBUR LEAKAGE. 2. THE LEAKED LIQUID IS THE SHEATH LIQUID, NO ONE HAS TOUCHED IT, AND NO ONE HAS CAUSED INJURY. 3. FOR SCIENTIFIC RESEARCH USE, THE INSTRUMENT IS OUT OF WARRANTY, AND PAYMENT IS ACCEPTED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SUSPECT THE LEAKAGE WAS SHEATH FLUID, SO THE CHECKLIST WAS NON BIOHAZARD. BUT AFTER FSE ON SITE FOUND THE LEAKAGE WAS WASTE FLUID. SO THE EVENT DESCRIPTION WAS BIOHAZARD. ADDITIONAL INFORMATION: ACCORDING TO THE NOTE OF CASE IN THE SMAX. THE LEAKED LIQUID IS WASTE LIQUID. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, 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 LIQUID UNDER PRESSURE? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): NO. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. 5 DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): UNKNOWN. 7 WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO. FACSCALIBUR LEAKAGE. THE LEAKED LIQUID IS THE SHEATH LIQUID, NO ONE HAS TOUCHED IT, AND NO ONE HAS CAUSED INJURY. FOR SCIENTIFIC RESEARCH USE, THE INSTRUMENT IS OUT OF WARRANTY, AND PAYMENT IS ACCEPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365479 FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 342975 NA 00382903429752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown