BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 15241087 · Received August 17, 2022

    Report

    Report Number
    2916837-2022-00219
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    July 25, 2022
    Report Date
    October 31, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906635181
    PMA / PMN Number
    K201814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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: INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L12C INSTRUMENT USIVD, PART # 663518, AND SERIAL (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING CARRYOVER BETWEEN SAMPLE TESTS. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 26JUL2021 TO DATE 26JUL2022. COMPLAINT TREND: THERE ARE 10 COMPLAINTS RELATED TO CARRYOVER DUE TO TUBING; (B)(4) AND THIS ONE, (B)(4). DATE RANGE FROM 26JUL2021 TO DATE 26JUL2022. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 663518, SERIAL # (B)(4), FILE # 663518-663518-Z663518000079-106746710-20, 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 CARRYOVER BETWEEN SAMPLE TESTS WAS DUE TO A CLOGGED PINCH VALVE TUBING. THE CUSTOMER HAD INITIALLY REPORTED THE CARRYOVER OBSERVED ON THE INSTRUMENT AND A POA (PLAN OF ACTION) WAS DEVELOPED AS A SHORT TERM SOLUTION TO BE PERFORMED ON ALL OF THAT CUSTOMER¿S INSTRUMENTS DUE TO THE REPEATED OCCURRENCES. THIS POA INCLUDES PARTS REPLACEMENTS FOR THE V8 TUBING, ORANGE SIT WASTE TUBING, AND BLACK SIT FITTING AS WELL AS A SIT FLUSH MODE CHECK FOR THE FLUSHING VOLUME AND ASPIRATION PUMP PERFORMANCE. THE LYRIC CORE TEAM OR PAVE TEAM WILL BE DEVELOPING A LONG TERM SOLUTION IN THE FUTURE. THE POA WAS INITIATED AND COMPLETED IN SEPTEMBER AND THERE HAVE BEEN NO ADDITIONAL INSTANCES OF CARRYOVER ON THIS INSTRUMENT. THE FSE (FIELD SERVICE ENGINEER) INVOLVED IN THIS ACTION WILL CONTINUE TO MONITOR THE PERFORMANCE OF THE INSTRUMENT BUT IT SEEMS TO BE FUNCTIONING AS EXPECTED AT THIS TIME. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PARTS ARE NOT RETURNABLE. ALTHOUGH THE ERRONEOUS RESULTS OCCURRED WHILE USING PATIENT SAMPLES, THE CUSTOMER CONFIRMED THAT THE ERRONEOUS RESULTS WERE NOT USED AND NO PATIENTS WERE HARMED. ADDITIONALLY, THE ERRONEOUS RESULTS DID NOT CAUSE A DELAY IN THE TREATMENT OF ANY PATIENTS. THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSIS DECISION AND WAS REPORTED TO BD AS NOT EXPECTED. THE CUSTOMER CONFIRMED THAT THE PATIENT SAMPLE WAS RERUN AGAIN LATER BEFORE ADVISING ANY TREATMENT. PROPER DAILY AND MONTHLY CLEANING PROCEDURES CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD FACSLYRIC¿ CLINICAL SYSTEM INSTRUCTIONS FOR USE, #23-19938-02, REV. 1/VERS. A. 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: (B)(6) 2020. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: SUBJECT / REPORTED: SIT DRIPPING / SAMPLE CARRYOVER. PROBLEM DESCRIPTION: WASTE TUBING STAYING CRIMPED AT PINCH VALVE CAUSING SIT TO DRIP AND OR SAMPLE CARRYOVER. CASE COMMENT SUMMARY: THIS ISSUE IS UNDER INVESTIGATION AND A LONG TERM SOLUTION WILL BE DEVELOPED BY PAVE OR LYRIC CORE TEAM. INITIAL STEP: ADD V8 SILICONE TUBING TO PM KIT. SHORT TERM SOLUTION: V8 TUBING REPLACED IN ALL LABCORP INSTRUMENTS. POA: PART REPLACEMENT (SILICONE V8 TUBING, ORANGE SIT WASTE TUBING, BLACK SIT FITTING) AND SIT FLUSH MODE CHECK (FLUSHING VOLUME, ASPIRATION PUMP PERFORMANCE) WILL BE EXECUTED TO THE END OF AUGUST. 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 # 10000063058RA, REV. 07/VERS. AA, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES, NO. TFS: 89227. ID: LIBIVD-RA-247 3.1.25. REG STATUS: IVD; RUO. HAZARD: INSTRUMENT TEMPORARILY INOPERABLE. SOURCE: SIT FMEA. CAUSE: SAMPLE LINE COLLAPSES PREVENTING SAMPLE DELIVERY. TUBING BECOMES . WORN/DAMAGED DURING "STINGER" OPERATION. LOW EVENT RATE. HARMFUL EFFECTS: 1) DELAY IN RESULTS. 2) TUBING MUST BE REPLACED. 3) CUSTOMER ANNOYANCE. RISK CONTROL: PROPER SERVICE LOOPS FOR PEEKSIL TUBE SO THAT IT DOES NOT WEAR AND KINK AT THE CONNECTION POINTS. RELIABILITY TEST TO PROVIDE ESTIMATE LIFE OF PEEKSIL TUBE AND RECOMMENDED REPLACEMENT SCHEDULE. RELIABILITY SIT PROTOCOL. REQ LINK (TFS ID): N/A IMPLEMENTATION VERIFICATION: RELIABILITY LIFE TESTING COMPLETED VIA PROTOCOL. PROTOCOL NAME: LIBERTY SIT RELIABILITY TEST PROTOCOL, LIBIVD-SE-15-72P. EFFECTIVENESS VERIFICATION: PUBLISHED RELIABILITY REPORT WHICH DEMONSTRATED AT LEAST 1.5 YEARS OF LIFE WITH NO SIGNIFICANT DAMAGE OR KINKS. REPORT NAME: LIBERTY SIT RELIABILITY REPORTLIBIVD-SE-15-72F. PROBABILITY: 2. SEVERITY: 2. RISK INDEX: 4. RESIDUAL RISK EVALUATION: A. NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT :YES, NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE CARRYOVER BETWEEN SAMPLE TESTS WAS DUE TO A BLOCKED V8 PINCH VALVE TUBING. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE FLUIDIC LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A BLOCKED V8 PINCH VALVE TUBING. THE CUSTOMER HAD REPORTED A REOCCURRING ISSUE WITH THEIR LYRIC SYSTEMS REGARDING CARRYOVER. THE CAUSE WAS FOUND TO BE DUE TO A BLOCKED V8 PINCH VALVE TUBING AND THE REPAIRS LISTED IN THE PLAN OF ACTION HAVE BEEN COMPLETED (REPLACEMENT OF SILICONE V8 TUBING, ORANGE SIT WASTE TUBING, BLACK SIT FITTING, SIT FLUSH MODE CHECK). NO FURTHER INSTANCES OF CARRYOVER HAVE BEEN REPORTED ON THIS INSTRUMENT AND IT SEEMS TO BE FUNCTIONING AS EXPECTED, BUT WILL BE MONITORED TO CONFIRM THE EFFECT OF THE POA. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE ERRONEOUS RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. SUPPORTING DOCUMENT: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ THE WASTE TUBING STAYING CRIMPED AT PINCH VALVE CAUSING SIT TO DRIP AND OR SAMPLE CARRYOVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ THE WASTE TUBING STAYING CRIMPED AT PINCH VALVE CAUSING SIT TO DRIP AND OR SAMPLE CARRYOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917265 BD FACSLYRIC¿ FLOW CYTOMETRIC REAGENTS AND ACCESS OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA 00382906635181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown