BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS LYSE WASH ASSISTANT

    MDR report key: 11619570 · Received April 6, 2021

    Report

    Report Number
    2916837-2021-00148
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    August 5, 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
    BE
    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, PART # 337146 AND SERIAL # (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON THE INSTRUMENT SHOWING SIGNS OF A CARRYOVER ISSUE. ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM (B)(6) 2020 TO (B)(6) 2021. ¿ COMPLAINT TREND: THERE ARE 5 COMPLAINTS RELATED TO THE INSTRUMENT SHOWING A CARRYOVER ISSUE; DATE RANGE FROM (B)(6) 2020 TO (B)(6) 2021. ¿ 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ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF THE OBSERVED CARRYOVER COULD NOT BE DETERMINED, BUT MAY HAVE BEEN DUE TO AN OUTDATED CARRYOVER PROTOCOL BEING USED. THE CUSTOMER INITIALLY REPORTED THE ISSUE OF CARRYOVER IN WO-01829904, AND AN FSE WAS SENT ONSITE IN WO-01830065 TO OBSERVE THE INSTRUMENT. THE FSE TESTED THE INSTRUMENT TO VERIFY IT WAS WORKING AS INTENDED, THEN ASKED APPLICATION SUPPORT TO CONTACT THE CUSTOMER AND EXPLAIN BD¿S CARRYOVER PROTOCOL. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. CARRYOVER WITH THIS INSTRUMENT WAS OBSERVED BY THIS CUSTOMER ON 12MAR2021 IN WO-1829904, AND WAS REPAIRED ON 02APR2021 IN WO-01830065. THE CURRENT LWA CARRYOVER PROTOCOL (23-23520-00) WAS LAST UPDATED IN NOVEMBER 2020, AND IT OUTLINES THE PROPER METHOD IN PREPARING THE SAMPLES AND RUNNING ANALYSES ON THOSE SAMPLES. NO¿PATIENT WAS TREATED¿NOR HARMED FROM INCORRECT RESULTS AS THE RESULTS WERE CAPTURED PRIOR¿TO ANY DIAGNOSIS DECISION AND¿WERE REPORTED¿TO BD AS NOT EXPECTED. 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 #: 01829904 / 01830065, CASE # (B)(4) INSTALL DATE: 01DEC2017. DEFECTIVE PART NUMBER: N/A WORK ORDER NOTES: O SUBJECT / REPORTED: 337146 - BD FACS LYSE WASH ASSISTANT ¿ CARRYOVER O PROBLEM DESCRIPTION: CUSTOMER REPORTS A CARRYOVER ISSUE. O WORK PERFORMED: TESTED INSTRUMENT AND IT'S WORKING AS IT SHOULD. TECHNICAL SERVICE CANNOT TEST INSTRUMENT WITH BLOOD SAMPLES. ASKED APPLICATION SUPPORT TO CONTACT CUSTOMER TO EXPLAIN BD PROTOCOL HOW TO CALCULATE CARRY OVER. SEE MAIL O CAUSE: CUSTOMER IS NOT USING BD PROTOCOL TO CALCULATE CARRY OVER O SOLUTION: TEST INSTRUMENT AND ASKED APPLICATION SUPPORT TO ASSIST CUSTOMER WITH BD PROTOCOL ¿ 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: GPPD0010-03. 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 RESULTS THE ROOT CAUSE OF THE OBSERVED CARRYOVER COULD NOT BE DETERMINED, BUT MAY HAVE BEEN DUE TO AN OUTDATED CARRYOVER PROTOCOL BEING USED. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE OBSERVED CARRYOVER COULD NOT BE DETERMINED, BUT MAY HAVE BEEN DUE TO AN OUTDATED CARRYOVER PROTOCOL BEING USED. THE FSE TESTED THE INSTRUMENT AND CONFIRMED THAT IT WAS WORKING AS INTENDED. THEY THEN ASKED AN APPLICATION SPECIALIST TO CONTACT THE CUSTOMER TO ASSIST THEM WITH BD¿S CARRYOVER PROTOCOL. NO ONE WAS HARMED OR INJURED DUE TO THIS INCIDENT, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE ERRONEOUS RESULTS. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACS¿ LYSE WASH ASSISTANT THERE WAS CARRYOVER WHILE RUNNING PATIENT SAMPLES. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS A CARRYOVER ISSUE. INFORMATION FROM CHECKLIST - PATIENT SAMPLE ISSUE: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD FACS¿ LYSE WASH ASSISTANT THERE WAS CARRYOVER WHILE RUNNING PATIENT SAMPLES. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS A CARRYOVER ISSUE. INFORMATION FROM CHECKLIST - PATIENT SAMPLE ISSUE: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520901 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