BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC

    MDR report key: 11636942 · Received April 8, 2021

    Report

    Report Number
    2916837-2021-00160
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 17, 2021
    Report Date
    September 10, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 3L12C INSTRUMENT CEIVD, PART # 663029, SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING 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 17MAR2020 TO 17MAR2021. COMPLAINT TREND: THERE ARE 3 COMPLAINTS RELATED TO A LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN INSTRUMENT DUE TO WORN CONNECTORS. DATE RANGE FROM 17MAR2020 TO 17MAR2021. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 663029 SERIAL # (B)(6), FILE # 663029-663029-R663029000029-106296412-19, 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 LEAK WAS DUE TO A WORN WASTE LINE FITTING. THE FSE (FIELD SERVICE ENGINEER) OBSERVED THE LEAKAGE AND FOUND THAT IT ORIGINATED FROM A TUBING CONNECTION AT THE OUTPUT OF THE WASTE PUMP. THE FSE REPLACED THE CONNECTORS AND TESTED THE INSTRUMENT FOR FURTHER LEAKAGES. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PART 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 #: 01836666, CASE # (B)(4). INSTALL DATE: 03SEP2019. DEFECTIVE PART NUMBER: 642160 BARB INSR ASSEMBLY 1/4-28FTG.17 BARB PPL WORK ORDER NOTES: SUBJECT / REPORTED: 663029 - FACSLYRIC - LEAKAGE FROM THE LEFT BACK CORNER PROBLEM DESCRIPTION: CUSTOMER REPORTS THAT DURING A MONTHLY CLEAN THE LEFT BACK CORNER OF THE INSTRUMENT STARTED LEAKING FLUID. WORK PERFORMED: JF 18/3/21: LEAKING OBSERVED FROM TUBING CONNECTION AT OUTPUT OF WASTE PUMP. REPLACE CONNECTOR. TEST INSTRUMENT WITH NO FURTHER SIGNS OF LEAKING OBSERVED. FULL OPERATIONAL CHECK AND TEST OF SYSTEM WITH NO ISSUES OBSERVED. PASSED LASER SETUP ALL OK. CAUSE: WORN WASTE LINE FITTING. SOLUTION: INSTRUMENT RETURNED TO CUSTOMER IN FULL WORKING ORDER. FITTING REPLACED PART NUMBER=642160. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE PART THAT WAS REPLACED 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. TFS: 89177 . 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 . 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 LINE FITTING. 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 LINE FITTING. THE FSE IDENTIFIED THE LOCATION OF THE LEAKAGE AND REPLACED THE WORN FITTING. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED, AND FUNCTIONING AS EXPECTED WITH NO FURTHER LEAKAGES. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACSLYRIC¿ BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER/PATIENT IMPACT. CUSTOMER REPORTS THAT DURING A MONTHLY CLEAN THE LEFT BACK CORNER OF THE INSTRUMENT STARTED LEAKING FLUID. 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 WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? 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 FACSLYRIC¿ BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER/PATIENT IMPACT. CUSTOMER REPORTS THAT DURING A MONTHLY CLEAN THE LEFT BACK CORNER OF THE INSTRUMENT STARTED LEAKING FLUID. 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 WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530621 BD FACSLYRIC NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1