BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS LYSE WASH ASSISTANT

    MDR report key: 11627830 · Received April 7, 2021

    Report

    Report Number
    2916837-2021-00157
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 16, 2021
    Report Date
    September 28, 2021
    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
    BR
    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 BD FACS LYSE WASH ASSISTANT (LWA), PART # 337146, AND SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT OF CARRYOVER ISSUES. MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 17MAR2020 TO DATE 17MAR2021. COMPLAINT TREND: THERE ARE 7 COMPLAINTS RELATED TO THE ISSUE OF CARRYOVER. DATE RANGE FROM 017MAR2020 TO DATE 17MAR2021. 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. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICEMAX, IT WAS DETERMINED THAT THERE WAS NO CARRYOVER OBSERVED WITHIN THIS INSTRUMENT ACCORDING TO THE NEW CARRYOVER PROTOCOL. THE CUSTOMER REPORTED THE ISSUE OF CARRYOVER DURING ANOTHER CASE (#(B)(4)) AND WAS RESOLVED IN (B)(4). THIS WAS CONFIRMED AS STATED IN THE INTERNAL BD COMMENTS OF THIS COMPLAINT OF TRACKWISE, AND NO NEW WORK ORDER WAS CARRIED OUT BECAUSE OF THE RESOLUTION. NO ISSUE WAS FOUND FROM THE INSTRUMENT AND WAS PERFORMING AS EXPECTED. A NEW LWA CARRYOVER PROTOCOL ((B)(4) REV. 1/VERS. A) WAS RELEASED IN NOVEMBER, 2020 THAT DESCRIBES THE PROPER METHOD IN PREPARING THE SAMPLES AND RUNNING ANALYSES ON THESE SAMPLES. USING THIS NEW PROTOCOL, THE CUSTOMER STATED THAT THEY NO LONGER OBSERVED CARRYOVER AND THAT THERE WERE NO FURTHER ISSUES ON THAT INSTRUMENT. TASK (B)(4), 1F. ADDITIONAL INFORMATION, CONFIRMS THAT NO PATIENT SAMPLES OR PATIENT WERE AFFECTED NOR WERE THERE ERRONEOUS RESULTS. THE SAFETY RISK FOR CARRYOVER BETWEEN SAMPLES IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: N/A CASE # (B)(4) (ISSUE RESOLVED IN (B)(4)). INSTALL DATE: (B)(6) 2020. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: N/A. SUBJECT / REPORTED: FLIGHT: CARRYOVER LWA TEST. PROBLEM DESCRIPTION: FLIGHT: CARRYOVER LWA TEST. WORK PERFORMED: N/A. CAUSE: N/A. SOLUTION: N/A. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO REPLACED PARTS. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 337146RA, REV. 02/VERS. C, 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. ID: 2.1.1. HAZARD: CARRYOVER. CAUSE: CLOGGED ORIFICE. HARMFUL EFFECTS: INCORRECT RESULTS, DAMAGED INSTRUMENT. RISK CONTROL: REPLACE ORIFICE AT EACH PM INTERVAL. IMPLEMENTATION VERIFICATION: RELIABILITY TESTING IN SV LAB; PROTOCOL: (B)(4) REV A. EFFECTIVENESS VERIFICATION: SYSTEM CHARACTERIZATION SUMMARY REPORT LWA CARRYOVER EVALUATION PHASE III VERSION 1.0 10/MAR/2010. 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 THE ROOT CAUSE WAS DUE TO AN OUTDATED PROCEDURE FOR PROPER SAMPLE PREPARATION. CONCLUSION: BASED ON THE INVESTIGATION THE ROOT CAUSE OF CARRYOVER ON THE LWA WAS DUE TO AN OUTDATED SAMPLE PREPARATION PROCEDURE. ALTHOUGH THE CUSTOMER REPORTED THE ISSUE OF CARRYOVER, IT WAS CONFIRMED THAT IT WAS NOT, BASED ON THE NEW PROTOCOL THAT WAS PROVIDED. USING THIS NEW PROTOCOL THE CUSTOMER NO LONGER OBSERVED CARRYOVER AND ERRONEOUS RESULTS. AFTER THE EVALUATION ON CARRYOVER, THE INSTRUMENT CONTINUED TO RUN AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO PATIENTS WERE HARMED FROM ANY POTENTIAL ERRONEOUS RESULTS. THE SAFETY RISK FOR CARRYOVER BETWEEN SAMPLES IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED DURING TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: CARRYOVER LWA TEST.

    Additional Manufacturer Narrative · 1

    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 FACS" (B)(6) ASSISTANT CARRYOVER OCCURRED DURING TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: CARRYOVER LWA TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526731 BD FACS LYSE WASH ASSISTANT STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 337146 NA 00382903371464

    Patients

    Seq Age Sex Outcome Treatment
    1