BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCOUNT INSTRUMENT SYSTEM

    MDR report key: 10766216 · Received October 30, 2020

    Report

    Report Number
    2916837-2020-00220
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Date of Event
    October 12, 2020
    Report Date
    June 17, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903378586
    PMA / PMN Number
    K933486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACSCOUNT INSTRUMENT SYSTEM, PART # 337858, SERIAL # D33785803415. ¿ PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON A BROKEN WASTE CONNECTOR RESULTING IN BIOHAZARD LEAKAGE. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 12OCT2019 TO DATE 12OCT2020. ¿ COMPLAINT TREND: THERE ARE 2 COMPLAINTS RELATED TO A BROKEN WASTE CONNECTOR RESULTING IN BIOHAZARD LEAKAGE; PR# 1698887 AND THIS ONE, 1903233. DATE RANGE FROM 12OCT2019 TO DATE 12OCT2020. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #337858 SERIAL # D33785803415, FILE #337858-337858-D33785803415-100180479-14, 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 LEAKAGE OUTSIDE OF THE INSTRUMENT WAS A BROKEN BULKHEAD CONNECTOR. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THE ISSUE TO BE DUE TO THE BROKEN CONNECTOR BEFORE STARTING THE FIX. THE FSE CLEANED AND DECONTAMINATED THE FLUIDICS COMPARTMENT, TANKS, AND BENCH TOP. THEY THEN REPLACED THE MALE WASTE PANEL MOUNT CONNECTOR WITH A MALE NON-PANEL MOUNT CONNECTOR AND RAN A CLEANING CYCLE TO VERIFY THE LEAK WAS GONE. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PART WAS NOT RETURNABLE AND WAS SCRAPPED. AFTER COMPLETING THE REPAIR THE INSTRUMENT WAS RUNNING AS INTENDED. THERE WAS NO CONTAMINATION OF SAMPLES AND NO CUSTOMER OR PATIENT WAS HARMED BY THE ISSUE. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED AND FUNCTIONING AS EXPECTED. THE SAFETY RISK IS LOW, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 01642294, CASE # 01160326 INSTALL DATE: 13NOV2014 DEFECTIVE PART NUMBER: N/A WORK ORDER NOTES: O SUBJECT / REPORTED: BROKEN BULKHEAD O PROBLEM DESCRIPTION: THE CUSTOMER REPORTED THAT THE WASTE PANEL-MOUNT CONNECTOR IS BROKEN RESULTING IN WASTE LEAKING HENCE THEY ARE UNABLE TO USE THE INSTRUMENT. O WORK PERFORMED: CLEANED/DECONTAMINATED THE FLUIDICS COMPARTMENT, FLUIDICS TANKS AND BENCH TOP WHERE INSTRUMENT IS SITTING. REPLACED THE MALE WASTE PANEL-MOUNT CONNECTOR WITH A MALE NON-PANEL-MOUNT CONNECTOR. RAN CLEANING CYCLE TO ENSURE THERE WAS NO LEAKAGE. VERIFIED THE INSTRUMENT CVS AND REFERENCE BEAD SETUP. O CAUSE: HANDLING O SOLUTION: INSTRUMENT UP AND RUNNING ¿ 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 #337858FMEA, VERSION A / REVISION 2, FACSCOUNT FMEA WAS REVIEWED. NO NEW HAZARD HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO O ITEM: DHF 102-7; FACSCOUNT SW HAZARD ANALYSIS O FUNCTION: HARDWARE MALFUNCTIONS. O POTENTIAL FAILURE MODE: FLUIDIC MALFUNCTIONS O POTENTIAL CAUSES: FACSCOUNT SOFTWARE CAN DETECT A NUMBER OF PROBLEMS WITH THE SYSTEM HARDWARE. O LOCAL AND NEXT-LEVEL EFFECTS: SEVERAL FLUIDIC SYSTEM MALFUNCTIONS CAN AFFECT RESULTS, AND ARE THEREFORE MONITORED BY THE SOFTWARE: - FLOWRATE TOO LOW - FLOWRATE TOO HIGH - SHEATH TANK LEVEL TOO LOW - WASTE TANK LEVEL TOO HIGH O HAZARDS: NONE O END EFFECTS: INOPERABLE O CURRENT CONTROLS: 1. THE FLOWRATE IS CHECKED BY MONITORING THE BEAD EVENT RATE DURING DATA ACQUISITION. IF THIS EVENT RATE IS OUTSIDE OF ACCEPTABLE LIMITS, THE RESULTS ARE SUPPRESSED AND THE USER IS NOTIFIED WITH AN ERROR MESSAGE. 2. SHEATH AND WASTE TANKS HAVE SENSORS WHICH INDICATE IF THEY ARE EMPTY OR FULL, RESPECTIVELY. THESE SENSORS ARE READ BY SOFTWARE BEFORE EACH PAIR OF SAMPLES OR CONTROLS IS RUN, BEFORE EACH CLEANING CYCLE, AND BEFORE EACH DRAIN CYCLE. IF EITHER OF THE SENSORS IS TRIGGERED, THE USER IS NOTIFIED WITH ERROR MESSAGES ON BOTH THE LCD AND THE PRINTOUT. O PROBABILITY: 2 O SEVERITY: 1 O RISK INDEX: 2 O OUTPUT: V&V TESTED MITIGATION(S) SUFFICIENT ¿YES ¿NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE WAS DUE TO A WORN WASTE CONNECTOR. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE CUSTOMER SEEING BIOLEAKAGE FROM THE FACSCOUNT INSTRUMENT WAS DUE TO A WORN WASTE CONNECTOR. THE FSE CONFIRMED THE ISSUE CLEANED THE INSTRUMENT, REPLACED THE PART AND PERFORMED A CLEANING CYCLE TO VERIFY THE LEAK WAS GONE. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED, AND FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED. THE SAFETY RISK IS LOW, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WASTE TANK LINE WAS LEAKING WITH A BD FACSCOUNT¿ INSTRUMENT SYSTEM. THERE WAS NO REPORT OF ANY HARM TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN WASTE CONNECTOR WAS THE WASTE LEAK MIXED WITH BLEACH OR DECONTAMINANT? R. NO WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? R. NOT CONTAINED WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? R. YES WAS THERE SPRAY OF FLUID UNDER PRESSURE? R. NO WHAT WAS THE FLUID THAT LEAKED? R. BIOHAZARD WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? R. WASTE LINE WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? R. NO

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WASTE TANK LINE WAS LEAKING WITH A BD FACSCOUNT¿ INSTRUMENT SYSTEM. THERE WAS NO REPORT OF ANY HARM TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN WASTE CONNECTOR. WAS THE WASTE LEAK MIXED WITH BLEACH OR DECONTAMINANT? NO . WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. WHAT IS THE SOURCE OF LEAK WASTE LINE OR NON-WASTE LINE? WASTE LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230360 BD FACSCOUNT INSTRUMENT SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 337858 NA 00382903378586

    Patients

    Seq Age Sex Outcome Treatment
    1 Other