BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 15513181 · Received September 30, 2022

    Report

    Report Number
    2916837-2022-00258
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    September 1, 2022
    Report Date
    November 10, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    PER
    UDI-DI
    00382906472052
    PMA / PMN Number
    K131301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY INVESTIGATION RESULTS NO CAPA IS NEEDED(B)(4); PN: 647205; SPAIII; SN: (B)(6); DATE REPORTED: 09/01/2022.INVESTIGATION SUMMARY:¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6).¿ PROBLEM STATEMENT: CUSTOMER REPORTED: WASH WELL OVERFLOW.¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 01SEP2021 TO DATE 01SEP2022 (ROLLING 12 MONTHS)¿ COMPLAINT TREND: THERE ARE 7 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 01SEP2021 TO DATE 01SEP2022 (ROLLING 12 MONTHS) O COMPLAINT DATA ATTACHED¿ INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: CLEARED THE INTERNAL PASSAGES OF THE WASH PUMP AND FLUSHED THE IN-LINE WASTE FILTER. REPLACED THE INLET QUICK-CONNECT FITTING TO THE FILTER AS IT IS A NORMAL POINT OF CLOGGING. NORMAL WASTE FLOW WAS RETURNED, AND THE WASH STATION NO LONGER FLOODED. NO CALIBRATED EQUIPMENT USED. CLEARING THE CLOG IN THE WASH PUMP RESOLVED THE REPORTED ISSUE. THE INSTRUMENT IS OPERATING AS INTENDED AND IS TESTING WITHOUT ERRORS.O NO FURTHER ISSUESO SAMPLE PREPARATION WAS NOT AFFECTED. O THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS.¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 02599489INSTALL DATE: 31AUG2009DEFECTIVE PART NUMBER: 640521 ¿ COUPLING INSERT VALVEWORK ORDER NOTES:O SUBJECT / REPORTED: WASH WELL OVERFLOWO PROBLEM DESCRIPTION: WASH TOWER OVERFLOWEDO CAUSE: CLOGGED WASH PUMP AND INLINE FILTERO WORK PERFORMED: CLEARED BLOCKAGE FROM PUMP AND INLINE FILTERO SOLUTION: CLEARED BLOCKAGE FROM PUMP AND INLINE FILTER¿ RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PARTS¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: X0006 AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.¿ RISK ANALYSIS: O RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED.O HAZARD(S) IDENTIFIED? ¿YES ¿NO¿ HAZARD ID: 3.1.29 _¿ HAZARD: ENVIRONMENTAL BIOHAZARD¿ SEVERITY: 5¿ PROBABILITY: 1¿ RISK INDEX: 5O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__O RISK CONTROL:_AFAP_____O MITIGATION(S) SUFFICIENT ¿YES ¿NO¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED WASH PUMP AND INLINE FILTER¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL REPORT THE COMPLAINT WAS CONFIRMED FOR WASH TOWER OVERFLOWED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THE WASH WELL WAS OVERFLOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS STATED THAT THE WASH WELL OVERFLOW. IT WAS REPORTED BY THE CUSTOMER THAT THE WASH WELL OVERFLOW. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THATLEAKED? BIOHAZARD. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE. (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? WAS CUSTOMER/BD PERSONNEL HARMED/INJURED?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THE WASH WELL WAS OVERFLOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS STATED THAT THE WASH WELL OVERFLOW. IT WAS REPORTED BY THE CUSTOMER THAT THE WASH WELL OVERFLOW. 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO. 6. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. 7. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? 8. WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? 9. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? 10. WAS CUSTOMER/BD PERSONNEL HARMED/INJURED?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616729 BD FACSLYRIC¿ BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD PER BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 647205 00382906472052

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown