BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ LYSE WASH ASSISTANT

    MDR report key: 14837093 · Received June 27, 2022

    Report

    Report Number
    2916837-2022-00163
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    June 14, 2022
    Report Date
    September 22, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    UDI-DI
    00382903371464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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: ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 14JUN2021 TO 14JUN2022. ¿ COMPLAINT TREND: THERE ARE 8 COMPLAINTS RELATED TO THE ISSUE OF THE INSTRUMENT'S WASTE TANK LEAKING OUTSIDE OF THE INSTRUMENT; PR#3358710, 3478361, 3616695, 4111868, 4400830, 4400840, 4400846, AND THIS ONE, 5376473. DATE RANGE FROM 14JUN2021 TO 14JUN2022. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 337146 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 WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT COULD NOT BE DETERMINED. AN FSE (FIELD SERVICE ENGINEER) WAS SENT ONSITE TO OBSERVE THE ISSUE AND STARTED BY INSPECTING THE INSTRUMENT WHICH WAS FOUND TO BE CLEAN. THEY THEN RAN A FULL SAMPLE RACK WITH 40 TUBES TO CHECK FOR LEAKAGES BUT THERE WERE NO LEAKAGES FOUND. THE INSTRUMENT WAS FUNCTIONING AS EXPECTED AND NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. THE LEAKAGE WAS NOT UNDER PRESSURE AND DID NOT SIGNIFICANTLY INCREASE THE RISK OF EXPOSURE. 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: 11SEP2017. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: O SUBJECT / REPORTED: 337146 - BD FACS LYSE WASH ASSISTANT - LEAKAGE FROM RIGHT SIDE OF THE INSTRUMENT. O WORK PERFORMED: INSPECTION OF THE INSTRUMENT. THERE IS NO SIGNS OR TRACES FROM ANY LEAKAGE INSIDE THE INSTRUMENT. THE BOTTOM AND ALL PARTS ARE VERY CLEAN. RAN A FULLY LOADED SAMPLE RACK ( 40 TUBES ) AND CHECKED WITH A LIGHT FOR SIGNS OF A LEAKAGE. ALL TUBINGS ARE WELL CONNECTED, THERE 'S NO LEAKS NOR ANY SAMPLE WELL FLOODING. COULD NOT FIND ANY ISSUE. IT IS POSSIBLE THAT THE WASTE CONTAINER OF FROM THE CUSTOMER HAS A LITTLE CRACK ON THE FRONT. THAT WOULD EXPLAIN THE LEAKAGE UNDERNEATH THE INSTRUMENT, AS THE WASTE CONTAINER IS SLIGHTLY STICKING OUT OF THE INSTRUMENT AT THE FRONT SIDE. O CAUSE: NO ISSUE FOUND. O SOLUTION: NO ISSUE FOUND, MIGHT BE AN EXTERNAL PROBLEM. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO REPLACED PARTS DURING THIS VISIT. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 337146FMEA, REV. 04/VERS. D, LYSE WASH ASSISTANT FMEA DISINFECTANT PROJECT WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES NO O ID: 20.1. O ITEM: BD DISINFECTANT . O FUNCTION: CONTAIN THE WASTE. O POTENTIAL FAILURE MODE: INTEGRITY OF WASTE TANK COMPROMISED. O POTENTIAL CAUSES: INCOMPATIBILITY OF ANTIFOAM WITH PP WASTE TANK MATERIAL. O LOCAL AND NEXT-LEVEL EFFECTS: WASTE LEAKS OUT OF THE TANK. O HAZARDS: CHEMICAL/BIOHAZARD DUE TO INCOMPATIBLE MATERIAL/CHEMICAL REACTION. O RISK CONTROLS: DISINFECTANT ADDED TO WASTE TANK; SAMPLES LYSED AND/OR FIXED; ANTI-FOAM MSDS. O EFFECTIVENESS VERIFICATION: REFER TO MEMO: STERIS VESTA SYDE SQ PRODUCT CHEMICAL COMPATIBILITY WITH ANTI-FOAM AND WASTE TANK. O PROBABILITY: 1 O SEVERITY: 4 O RISK INDEX: 4 O OUTPUT: NONE. MITIGATION(S) SUFFICIENT YES NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT COULD NOT BE CONFIRMED. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT COULD NOT BE CONFIRMED. THE FSE PERFORMED AN INSPECTION ON THE INSTRUMENT UPON THEIR ARRIVAL. THEY DIDN¿T FIND ANY TRACES OF LEAKAGES WITHIN THE INSTRUMENTS AND THE INSTRUMENT SEEMED CLEAN. THE FSE THEN RAN A FULLY LOADED SAMPLE TUBE RACK TO OBSERVE FOR LEAKAGES, BUT THERE WERE NO LEAKS OR OVERFLOWS. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED, AND FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE LEAKAGE. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. ¿ SUPPORTING DOCUMENT:

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE CUSTOMER REPORTS THERE IS A LEAKAGE FROM THE RIGHT HAND SIDE OF THE INSTRUMENT. IT APPEARS THE LEAKED FLUID IS WASTE SOLUTION AS IT IS SLIGHTLY RED IN COLOR. "WAS THE LEAK LIQUID OR AIR?" LIQUID. "WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT?" NOT CONTAINED. "WAS THERE SPRAY OF LIQUID?" NO. "WHAT WAS THE FLUID THAT LEAKED?" BIOHAZARD. "DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE?" AFTER WASTE LINE. "WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH?" NO. "WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID?" NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTS THERE IS A LEAKAGE FROM THE RIGHT HAND SIDE OF THE INSTRUMENT. IT APPEARS THE LEAKED FLUID IS WASTE SOLUTION AS IT IS SLIGHTLY RED IN COLOUR. ¿ WAS THE LEAK LIQUID OR AIR? LIQUID. ¿ WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. ¿ WAS THERE SPRAY OF LIQUID? NO. ¿ WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. ¿ DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. ¿ WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. ¿ WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017540 BD FACS¿ LYSE WASH ASSISTANT STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 337146 NA 00382903371464

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown