BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ LYSE WASH ASSISTANT

    MDR report key: 17067262 · Received June 5, 2023

    Report

    Report Number
    2916837-2023-00118
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 25, 2023
    Report Date
    August 15, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    UDI-DI
    00382903371464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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

    THE FOLLOWING FIELDS WAS UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX F CODE: F26. H.6. INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACS LYSE WASH ASSISTANT, PART # 337146, AND SERIAL #(B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING SAMPLES NOT LYSED CORRECTLY THAT OCCURRED ON 25MAY2023. UNEXPECTED RESULTS CAN NEGATIVELY IMPACT PATIENT DIAGNOSIS AND TREATMENT. THE INSTRUMENT UNDERWENT REPAIRS AND WAS FOUND TO BE FUNCTIONING AS EXPECTED, AND NEITHER THE CUSTOMER NOR ANY PATIENTS WERE HARMED BY THESE RESULTS. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE FOR PART # 337146. DATE RANGE FROM 25MAY2022 TO DATE 25MAY2023. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #337146 SERIAL # (B)(6), FILE #(B)(4) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. MANUFACTURING DATE: 16MAR2016. COMPLAINT HISTORY REVIEW: THERE ARE 5 COMPLAINTS RELATED TO THE ISSUE OF UNEXPECTED RESULTS FOR PART # 337146. PR#, (B)(4) INCLUDING THIS ONE 8041397. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION BECAUSE NO PARTS WERE REPLACED. ¿ SERVICE HISTORY REVIEW: REVIEW OF RELATED WORK ORDER #:(B)(4), CASE #: (B)(4). INSTALL DATE: 09MAY2016. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: O SUBJECT / REPORTED: 337146 - BD FACS LYSE WASH ASSISTANT- NOT PROPER LYSE CAUSED UNACCEPTABLE RESULT O PROBLEM DESCRIPTION: CUSTOMER LET US KNOW THAT THE LYSE HASN'T BEEN DONE PROPERLY SO, THERE IS UNACCEPTABLE RESULT ON COUNTING AND WASH. HOWEVER, THE SOLUTIONS HAVE SUFFICIENT VOLUME. ACCORDING TO THE CUSTOMER, IT'S AN INTERMITTENT ISSUE. O WORK PERFORMED: FSE PERFORMED TROUBLESHOOTING MEASURES WHICH INCLUDED RESEATING TUBINGS TO THE DISPENSE PROBE, RESEATING SEALS INSIDE THE CELL DISPENSE PROBE, CHECKING OF FLUIDICS LEAKAGE, VALVE FUNCTIONS, FLUSHING OF CELL WASH PROBE, DISPENSING OF LYSE AND FIX SOLUTIONS AND TANK LEVEL SENSORS. FSE FOUND LOOSE TUBING AT THE DISPENSE PROBE AND RESEATED ALL TUBINGS TO THE DISPENSE PROBE. FINAL CHECK: - RELIABILITY TEST (WITH FOOD COLOR) PERFORMED. - SYSTEM ATTRIBUTES IN BD DEVICE DATABASE CHECKED. THE INSTRUMENT PERFORMS ACCORDING TO THE INSTRUMENT SPECIFICATIONS AND IS READY FOR USE WITHOUT RESTRICTIONS. O CAUSE: LOOSE TUBING AT THE DISPENSE PROBE. O SOLUTION: RESEATED TUBING AT DISPENSE PROBE. O PARTS REPLACED: N/A. ¿ LABELING / PACKAGING REVIEW: N/A. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 337146RA, VERS. B, BD FACS¿ LYSE/WASH ASSISTANT RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES NO. O HAZARD ID #: 3.1.2. O HAZARD: 1. UN-PREPPED SAMPLE. 2. NO ANSWER. 3. LOSS OF SAMPLE. O CAUSE: DEFECTIVE VALVE. O HARMFUL EFFECTS: 1. DELAYED OR NO RESULTS. 2. INCREASED COST OF TEST DUE TO NEED TO RE-PREP THEN RERUN. 3. POOR RELIABILITY. O RESIDUAL PROBABILITY: 1 O RESIDUAL SEVERITY: 3 O RESIDUAL RISK INDEX: 3 ¿ POTENTIAL CAUSES: BASED ON THE INVESTIGATION, THE POTENTIAL CAUSE WAS DETERMINED TO BE LOOSE TUBINGS AT THE DISPENSE PROBE. ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE ACTIVITY REVIEW, THE POTENTIAL CAUSE WAS DETERMINED TO BE LOOSE TUBINGS AT THE DISPENSE PROBE. AN FSE (FIELD SERVICE ENGINEER) WENT ONSITE AND CONFIRMED THE ISSUE. TO RESOLVE THIS ISSUE, THE FSE PERFORMED TROUBLESHOOTING MEASURES AND CHECKS WHICH INCLUDED FLUIDICS LEAKAGE TESTS, PROPER FUNCTIONING OF VALVES, FLUSHING OF CELL WASH PROBE, DISPENSING OF LYSE AND FIX SOLUTIONS AND TANK LEVEL SENSORS. DURING TROUBLESHOOTING, THE FSE ENCOUNTERED LOOSE TUBINGS AT THE DISPENSING PROBE AFTER WHICH FSE PROCEEDED TO RESEAT THE TUBINGS AT THE DISPENSING PROBE. AFTERWARDS, FSE PERFORMED RELIABILITY TEST AND THE INSTRUMENT IS FUNCTIONING AS EXPECTED. THE FSE CONFIRMED THAT ERRONEOUS RESULTS ON PATIENT SAMPLES WERE NOT REPORTED TO THE CLINICIANSNO PATIENT WAS DIAGNOSED OR TREATED BASED ON THESE RESULTS. PROPER DAILY AND MONTHLY CLEANING PROCEDURES CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD FACS¿ LYSE WASH ASSISTANT INSTRUCTIONS FOR USE, #23-11113 REV. 02/VERS. A, STARTING PAGE 107. TROUBLESHOOTING PROCEDURES CAN BE FOUND IN THE IFU STARTING ON PAGE 145. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. ¿ CONCLUSION: BASED ON THE INVESTIGATION, THE COMPLAINT WAS CONFIRMED, AND THE POTENTIAL CAUSE OF THE UNEXPECTED RESULTS WAS DETERMINED TO BE LOOSE TUBINGS AT THE DISPENSING PROBE. THE FSE RESEATED THE TUBINGS AND SUBSEQUENT TESTING SHOWED THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO PATIENTS WERE DIAGNOSED OR TREATED BASED ON ANY ERRONEOUS RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. BASED ON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED BECAUSE THE ISSUE WAS RESOLVED AND THERE WAS NO IMPACT TO CUSTOMER AND PATIENT HEALTH OR SAFETY. ¿ SUPPORTING DOCUMENT: N/A. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACS¿ LYSE WASH ASSISTANT THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER LET US KNOW THAT THE LYSE HASN'T BEEN DONE PROPERLY SO, THERE IS UNACCEPTABLE RESULT ON COUNTING AND WASH. HOWEVER, THE SOLUTIONS HAVE SUFFICIENT VOLUME. ACCORDING TO THE CUSTOMER, IT'S AN INTERMITTENT ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACS¿ LYSE WASH ASSISTANT THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER LET US KNOW THAT THE LYSE HASN'T BEEN DONE PROPERLY SO, THERE IS UNACCEPTABLE RESULT ON COUNTING AND WASH. HOWEVER, THE SOLUTIONS HAVE SUFFICIENT VOLUME. ACCORDING TO THE CUSTOMER, IT'S AN INTERMITTENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021281 BD FACS¿ LYSE WASH ASSISTANT STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 337146 00382903371464

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown