BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 14519667 · Received May 26, 2022

    Report

    Report Number
    2916837-2022-00138
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 23, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE WAS FOUND TO BE A DEFECTIVE SHEATH FILTER ASSEMBLY. THE CUSTOMER NOTED THAT THE DISTILLED WATER WAS NOT CLEAR AND WAS CONCERNED ABOUT THE FUNCTIONING OF THE SIT (SAMPLE INJECTION TUBE) FLUSH. THE ROOT CAUSE OF THE FAULTY SIT FLUSH FUNCTIONING AND RESULTING CARRYOVER WAS CONFIRMED BY THE FSE (FIELD SERVICE ENGINEER) TO BE A DEFECTIVE SHEATH FILTER ASSEMBLY. THE FSE PERFORMED TESTS ON THE OPERATION OF ASPIRATOR AND FLUSH, AND THE OPERATION AND RESISTANCE OF THE V8 VALVE. HE REPLACED THE SILICONE TUBING OF THE SIT FLUSH CIRCUIT, AND THE SHEATH FILTER ASSEMBLY (PART NUMBER: 651451). NO PARTS WERE REQUESTED FOR EVALUATION. AFTER THE REPLACEMENT, THE INSTRUMENT WAS TESTED AND WAS PERFORMING AS EXPECTED. NO PATIENT WAS TREATED NOR HARMED FROM INCORRECT RESULTS. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. 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, PAGE 165. 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) 2019 DEFECTIVE PART NUMBER: 651451 WORK ORDER NOTES: SUBJECT / REPORTED: 663029 - FACSLYRIC 3L12C CEIVD INSTRUMENT - DOUBT ABOUT THE OPERATION OF THE SIT FLUSH. PROBLEM DESCRIPTION: IT APPEARS THAT THE DISTILLED WATER TUBE LOOKS SLIGHTLY PINK DURING THE DAY, SUGGESTING THAT THE SIT FLUSH IS NOT WORKING PROPERLY. WORK PERFORMED: FUNCTIONAL TEST OF PUMP P2 (ASPIRATOR) AND PUMP P1 (FLUSH) -> COMPLIANT. FUNCTION AND RESISTANCE TEST OF THE V8 VALVE -> COMPLIANT. REPLACEMENT OF THE SILICONE TUBING OF THE SIT FLUSH CIRCUIT. REPLACEMENT OF THE SHEATH FILTER ASSEMBLY (651451) -> COMPLIANT. PASSAGE OF THE CAB CALIBRATION BEADS -> COMPLIANT. PASSAGE OF CS&T BALLS LOT 1264820 -> PQC COMPLIANT. FUNCTIONAL AND COMPLIANT DEVICE ACCORDING TO BD SPECIFICATIONS. CAUSE: SHEATH FILTER ASSEMBLY FUYANT (651451) SOLUTION: REPLACING THE SHEATH FILTER ASSEMBLY. 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 # (B)(4), REV. 07/VERS. AA, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES/NO AZURE ID: (B)(4) ID: LIBIV D-RA100 3.1.7 REG STATUS: IVD; RUO HAZARD: INCORRECT OUTPUT FOR SAMPLES UP TO 1.5ML OR LESS. CAUSE: SAMPLE CARRYOVER ERROR - FLUIDIC. HARMFUL EFFECTS: EVENTS APPEAR IN WRONG TUBE (FALSE POSITIVE RESULT). RISK CONTROL: PROPER SIT FLUSHING BETWEEN SAMPLES. DROPLET CONTAINMENT TO MANAGE BACK DRIPPING INTO SAMPLES. REQ LINK (AZURE ID): (B)(4) LIBIVDFLD-292 SAMPLE PAUSE/RESUME 93170 LIBIVDDID-342 STANDARD CARRYOVER IMPLEMENTATION VERIFICATION: LIBIVD-15-09P LSVN-1008-DP SIT BACKFLOW CONTROL EFFECTIVENESS VERIFICATION: LIBIVD-15-09F LSVN-1008-DR 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 WAS DUE TO A FAULTY SHEATH FILTER ASSEMBLY. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE CUSTOMER WAS EXPERIENCING CARRYOVER ISSUES ON THE FACSLYRIC WAS DUE TO A FAULTY SHEATH FILTER ASSEMBLY. THE FSE CONFIRMED THE ISSUE BY REPLACING THE SILICONE TUBING OF THE SIT FLUSH CIRCUIT AND THE SHEATH FILTER ASSEMBLY. AFTER THE REPLACEMENT, THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ CARRYOVER BETWEEN PATIENT SAMPLES HAD OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT APPEARS THAT THE TUBE OF DISTILLED WATER HAS A SLIGHTLY PINK APPEARANCE AFTER AN ACQUISITION, SUGGESTING THAT THE SIT FLUSH IS NOT WORKING CORRECTLY. (B)(6) 2022 - ERRONEOUS RESULTS CONFIRMED AS NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ CARRYOVER BETWEEN PATIENT SAMPLES HAD OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT APPEARS THAT THE TUBE OF DISTILLED WATER HAS A SLIGHTLY PINK APPEARANCE AFTER AN ACQUISITION, SUGGESTING THAT THE SIT FLUSH IS NOT WORKING CORRECTLY. ON 25/MAY/22 - ERRONEOUS RESULTS CONFIRMED AS NO (EMAIL AVAILABLE IN THE ATTACHMENTS BELOW)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253633 BD FACSLYRIC¿ NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown