BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC

    MDR report key: 12252978 · Received July 30, 2021

    Report

    Report Number
    2916837-2021-00325
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 8, 2021
    Report Date
    October 7, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L10C INSTRUMENT RUO, PART # 662382, SERIAL # (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT OF A WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED WITHIN THE INSTRUMENT. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM (B)(6) 2020 TO (B)(6) 2021. ¿ COMPLAINT TREND: THERE ARE 8 COMPLAINTS RELATED TO A WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM (B)(6) 2020 TO (B)(6) 2021. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 662382 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 WORN WASTE CONNECTOR. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THE ISSUE AND REPLACED THE PART. NO PARTS WERE REQUESTED FOR EVALUATION AS THE CONNECTOR IS NOT RETURNABLE AND WAS DISCARDED. AFTER THE REPAIR THE INSTRUMENT WAS TESTED AND WAS PERFORMING AS EXPECTED WITH NO FURTHER LEAKS. ALTHOUGH THE LEAKAGE OF BIOHAZARDOUS MATERIAL CAN CAUSE HARM TO THE CUSTOMER FROM EXPOSURE TO SAMPLES AND CHEMICALS, THE CUSTOMER WAS NOT HARMED IN ANY WAY AS THEY HAD NOT COME IN CONTACT WITH THE LEAKAGE. ADDITIONALLY, THE LEAK WAS NOT UNDER PRESSURE AND DID NOT SPRAY, AND THUS DID NOT SIGNIFICANTLY INCREASE THE RISK OF EXPOSURE. THIS INSTRUMENT WAS BEING USED FOR RESEARCH PURPOSES, NOT CLINICAL TREATMENT, AND SO THIS INCIDENT DID NOT AFFECT OR DELAY THE DIAGNOSIS OF A PATIENT. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(6\4), CASE # (B)(4). INSTALL DATE: (B)(6) 2017. DEFECTIVE PART NUMBER: 642160 - BARB INSR ASSEMBLY 1/4-28FTG.17 BARB PPL. WORK ORDER NOTES: SUBJECT / REPORTED: THE INSTRUMENT IS LEAKING. PROBLEM DESCRIPTION: THE INSTRUMENT IS LEAKING. THERE IS FLUID ALL ON THE TABLE. WORK PERFORMED: REPLACED CONNECTOR. CAUSE: BROKEN CONNECTOR. SOLUTION: REPLACED CONNECTOR. ¿ 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 # 10000063058, REV. 03/VERS. X, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES, NO. O AZURE ID: (B)(4). ID: LIBIVD-RA-71 2.1.14. REG STATUS: IVD; RUO. HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. CAUSE: FAILED WASTE CONNECTION. HARMFUL EFFECTS: INJURY TO OPERATOR DUE TO SPRAYING OF WASTE. RISK CONTROL: ROBUST DESIGN CONNECTION TO THE TANK. THE WASTE CONNECTION TO THE CHASSIS IS HOUSED INSIDE THE SYSTEM. WASTE CAP REMOVED INTERLOCK. FOLLOW UNIVERSAL PRECAUTIONS INCLUDED IN USER DOCUMENTATION. REQ LINK (TFS ID): 93782 LIBIVD-DID-1585 NORMAL USE. IMPLEMENTATION VERIFICATION: LIBIVD-SE-15-84AR, LIBIVD-SE-15-72P, LIBIVD-SE-15-51IR EFFECTIVENESS VERIFICATION: LIBIVD-SE-15-84AR, LIBIVD-SE-15-72F, LIBIVD-SE-15-51IR. PROBABILITY: 1. SEVERITY: 1. RISK INDEX: 3. RESIDUAL RISK EVALUATION: A. NEW HAZARDS: NONE. O AZURE ID: (B)(4). ID: LIBIVD-RA-72 2.1.15. REG STATUS: IVD; RUO. HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. CAUSE: FAILED WASTE CONNECTION. HARMFUL EFFECTS: DAMAGE TO INSTRUMENT. RISK CONTROL: ROBUST DESIGN CONNECTION TO THE TANK. THE WASTE CONNECTION TO THE CHASSIS IS HOUSED INSIDE THE SYSTEM. SYSTEM SHALL BE DESIGNED TO ISOLATE FLUID FROM ELECTRICAL AND OPTICAL COMPONENTS. WASTE CAP REMOVED INTERLOCK. REQ LINK (TFS ID): 93748 LIBIVD-DID-1582 SHIELDING. IMPLEMENTATION VERIFICATION: LIBIVD-SE-15-84AR, LIBIVD-SE-15-53IR, LIBIVD-SE-15-72P. EFFECTIVENESS VERIFICATION: LIBIVD-SE-15-84AR, LIBIVD-SE-15-53IR, LIBIVD-SE-15-72F. PROBABILITY: 1. SEVERITY: 3. RISK INDEX: 3. RESIDUAL RISK EVALUATION: A. NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT YES, NO. ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN WASTE CONNECTOR. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN WASTE CONNECTOR. THE FSE CONFIRMED THE ISSUE AND REPLACED THE WORN WASTE CONNECTOR. AFTER THE REPAIR, THE INSTRUMENT WAS FUNCTIONING AS EXPECTED WITH NO FURTHER LEAKS. NO ONE WAS HARMED OR INJURED DUE TO THE INCIDENT, AND SINCE THE INSTRUMENT WAS NOT BEING USED FOR CLINICAL TREATMENT, NO PATIENTS WERE AFFECTED. 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 THAT WHILE USING BD FACSLYRIC¿ WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INSTRUMENT IS LEAKING. 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN. 6. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. 7. WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS A WASTE CONNECTOR. 10% BLEACH IS ADDED TO THE WASTE CONTAINER TO KILL ANY PATHOGENS.

    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 THAT WHILE USING BD FACSLYRIC¿ WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INSTRUMENT IS LEAKING. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS A WASTE CONNECTOR. 10% BLEACH IS ADDED TO THE WASTE CONTAINER TO KILL ANY PATHOGENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154042 BD FACSLYRIC NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1