BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS LYSE WASH ASSISTANT

    MDR report key: 11636934 · Received April 8, 2021

    Report

    Report Number
    2916837-2021-00162
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 17, 2021
    Report Date
    August 30, 2021
    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
    NC, US
    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 FACS LYSE WASH ASSISTANT, PART # 337146 AND SERIAL # (B)(6). PROBLEM STATEMENT: THE CUSTOMER SUBMITTED A COMPLAINT REGARDING A WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED WITHIN THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 17MAR2020 TO 17MAR2021. COMPLAINT TREND: THE ONLY COMPLAINT RELATED TO THE ISSUE OF A FLUID LEAK WITHOUT BLEACH NOT CONTAINED WITHIN THE INSTRUMENT IS THIS ONE; DATE RANGE FROM 17MAR2020 TO 17MAR2021. 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 LEAKAGE OF WASTE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN WASTE COUPLING. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THE ISSUE AND REPLACED THE WORN COUPLING. THEY THEN VERIFIED THAT THE INSTRUMENT WAS NO LONGER LEAKING, AND AFTER THE REPAIR THE INSTRUMENT WAS WORKING AS EXPECTED. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. ALTHOUGH THE LEAKAGE OF BIOHAZARDOUS MATERIAL HAS THE RISK OF CONTAMINATION, THE CUSTOMER DID NOT COME IN CONTACT WITH THE LEAKAGE AND WAS NOT HARMED IN ANY WAY. THE LEAKAGE WAS NOT UNDER PRESSURE AND THUS DID NOT SIGNIFICANTLY INCREASE THE RISK OF EXPOSURE. ADDITIONALLY, THIS INSTRUMENT WAS NOT BEING USED FOR CLINICAL DIAGNOSTIC TESTS AT THE TIME OF THE INCIDENT, AND THUS DID NOT POSE THE RISK OF AFFECTING PATIENT SAMPLES OR PATIENT TREATMENT. THE SAFETY RISK IS SEVERE, S4, THOUGH 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) 2011. DEFECTIVE PART NUMBER: 59-10090-05 - COUPL INS HOSE BARB PP ORN. WORK ORDER NOTES: SUBJECT / REPORTED: FLUID IS LEAKING. PROBLEM DESCRIPTION: FLUID IS LEAKING. WORK PERFORMED: REPLACED THE WORN FITTING AND VERIFIED THAT THE CONNECTION WAS NO LONGER LEAKING. CAUSE: MALE QUICK CONNECT WASTE COUPLING LEAKING WHERE IT ATTACHES TO THE WASTE TANK. SOLUTION: REPLACING THE FITTING RESOLVED THE REPORTED ISSUE. THE INSTRUMENT IS OPERATING AS INTENDED AND IS TESTING WITHOUT ERRORS. I HAVE RETURNED THE INSTRUMENT TO THE LAB FOR NORMAL USE. 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 # RA337408, REV. 01/VERS. A, BD FACS LYSE/WASH ASSISTANT (LWA) SYSTEM HAZARDS ANALYSIS REPORT WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. THE SEVERITY IN THIS FILE IS ¿8D¿ BASED ON A PAST SCALE RATING. THIS RATING IS EQUIVALENT TO ¿S4¿ ACCORDING TO THE RISK INDEX TABLE AND SOP6078-02¿REV. 12/VERS. J, WHEREBY THERE IS A SIGNIFICANT RISK TO THE PATIENT OR CUSTOMER. IN THIS CASE, HOWEVER, THERE WAS NO SPRAY OF FLUID NOR CONTACT WITH THE LEAKED FLUID, AND THUS THERE WAS LITTLE RISK OF INJURY TO THE CUSTOMER. ID: 2. CUSTOMER USE. HAZARD: NO ANSWER. TARGET & EFFECT: 1 ¿ HARM TO USER. CAUSE: 1.7.1 LEAKS FROM TANKS. BASIC EVENT: 1.7.1.1 LEAK IN WASTE TANK. INITIAL RISK: N/A. RISK CONTROLS: 1. DESIGN CHANGE ADDED RTV TO TANK ASSEMBLY TO PREVENT LEAK 2. LEAK TEST FOR TANK DURING FINAL MANUFACTURING TEST. FINAL RISK: 4D. COMMENTS: RISK WAS DETERMINED AFTER MITIGATION. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN WET CART WASTE TANK COUPLING. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN WET CART WASTE TANK COUPLING. THE FSE CONFIRMED THE ISSUE, REPLACED THE WORN COUPLING, AND VERIFIED THAT THE INSTRUMENT WAS NO LONGER LEAKING. 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 IS SEVERE, S4, THOUGH THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACS¿ LYSE WASH ASSISTANT WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID IS LEAKING. LEAK QUESTIONS FROM CHECKLIST IN SMAX:. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER THE WASTE LINE? AFTER THE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    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 FACS¿ LYSE WASH ASSISTANT WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID IS LEAKING LEAK QUESTIONS FROM CHECKLIST IN SMAX: WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER THE WASTE LINE? AFTER THE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATE/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
    534067 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