BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ LYSE WASH ASSISTANT

    MDR report key: 13424021 · Received February 2, 2022

    Report

    Report Number
    2916837-2022-00018
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 19, 2022
    Report Date
    March 7, 2022
    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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF THE ISSUE IS ONLY LIMITED TO BD FACS LYSE WASH ASSISTANT, PART # 337146 AND SERIAL # (B)(6). PROBLEM STATEMENT: THE CUSTOMER REPORTED A CARRYOVER ISSUE WITH THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 19JAN2021 TO 19JAN2022. COMPLAINT TREND: THERE ARE 8 COMPLAINTS RELATED TO THE ISSUE OF CARRYOVER ISSUE; DATE RANGE FROM 19JAN2021 TO 19JAN2022. 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 CARRYOVER BETWEEN SAMPLE TESTS WAS DUE TO WORN FLUIDICS FITTINGS AND TUBING. THE CUSTOMER HAD REPORTED THAT THE RESULTS GATHERED WHILE USING ONE OF THE LWAS WERE INCORRECT. THE CUSTOMER HAD REPLACED ALL THE FLUIDS IN THE FLUIDICS TANKS BUT THE ISSUE WAS STILL PRESENT. THE FSE (FIELD SERVICE ENGINEER) INSPECTED THE INSTRUMENT AND FOUND THAT AN AIR LEAKAGE WAS INTERFERING WITH THE CELL WASH CYCLES. THE WORN TUBING AND BARBED COUPLING (PN 343529) WERE REPLACED. ADDITIONALLY, THE V1 VALVE AND ASPIRATOR PUMP WERE REPLACED TO IMPROVE THE CELL WASH FLOW. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. AFTER THE REPAIR THE INSTRUMENT WAS TESTED AND FUNCTIONING AS EXPECTED. ALTHOUGH THE UNEXPECTED RESULTS WERE FROM PATIENT SAMPLES, NO PATIENT WAS TREATED NOR HARMED FROM INCORRECT RESULTS. THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSIS DECISION AND WAS REPORTED TO BD AS NOT EXPECTED. PROPER DAILY AND MONTHLY CLEANING PROCEDURES CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD FACS¿ LYSE WASH ASSISTANT SYSTEM INSTRUCTIONS FOR USE, #23-11113-01 REV. 1/VERS. A. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4), CASE # (B)(4). INSTALL DATE: 29SEP2017 DEFECTIVE PART NUMBER: 343529 - WHITE HOSE BARB INSERT COUPLING 1/8IN ID. 346340 - PUMP LIQUID 1/8 BARB. 648195 - VALVE 2/2 24VDC 1.4MM 3IN WIRE. WORK ORDER NOTES: O SUBJECT / REPORTED: TO MUCH CROSSOVER. O PROBLEM DESCRIPTION: TO MUCH CROSSOVER. O WORK PERFORMED: REPLACED THE ASPIRATOR PUMP, VALVE V1, TUBING AND CONNECTOR ON THE CELL WASH TANK. VERIFIED OPERATION PER THE SERVICE MANUAL. O CAUSE: AIR BUBBLES WERE CAUSING SPUTTERING DURING THE CELL WASH CYCLES. THIS WAS CAUSED BY POOR TUBING TO BARBED FITTING CONNECTION AT THE CELL WASH TANK BULKHEAD CONNECTION. REPLACED V1 AND THE ASPIRATOR PUMP TO IMPROVE THE CELL WASH FLOW. O SOLUTION: INSTRUMENT IS OPERATIONAL. RETURNED THE INSTRUMENT TO THE CUSTOMER. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. 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. O ID: 3.1.6. O HAZARD: LOSS OF SAMPLES. O CAUSE: BAD CONNECTOR. 2. OVERHEATED COMPONENTS. 3. INSUFFICIENT ELECTRICAL GROUNDING. O HARMFUL EFFECTS: DELAYED RESULTS. O RISK CONTROL: REPLACED FCI CONNECTOR WITH IMPROVED MOLEX CONNECTOR. ADDED COOLING FAN AND VENT HOLES TO THE REAGENT DOOR ASSEMBLY WHICH RESULTED IN 20 DEGREE REDUCTION TO DOOR INTERNAL TEMPERATURE. ADDED GROUND CABLE BETWEEN REAGENT DOOR AND MAIN CHASSIS TO COMPLETE CHASSIS GROUND CONNECTION TO DOOR. O IMPLEMENTATION VERIFICATION: RELIABILITY TESTING IN SV LAB¿ PROTOCOL GPPD0010-03 REV A. O EFFECTIVENESS VERIFICATION: SYSTEM LEVEL RELIABILITY TEST PROTOCOL AND REPORT. O PROBABILITY: 1. O SEVERITY: 3. O RISK INDEX: 3. O RESIDUAL RISK EVALUATION: A. O NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT ¿YES ¿NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE CARRYOVER WAS DUE TO WORN CONNECTORS AND TUBING. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE CARRYOVER WAS DUE TO WORN CONNECTORS AND TUBING. THE FSE INSPECTED THE INSTRUMENT AND FOUND THAT AIR BUBBLES WERE INTERFERING WITH THE CELL WASH CYCLES AND WAS DUE TO A POOR CONNECTION AT THE CELL WASH TANK BULKHEAD CONNECTION. THE FSE REPLACED THE FITTINGS AND TUBING TO RESOLVE THE AIR LEAKAGE, AND REPLACED THE V1 VALVE AND ASPIRATOR PUMP TO IMPROVE THE CELL WASH FLOW. NO ONE WAS HARMED OR INJURED, 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD FACS¿ LYSE WASH ASSISTANT HAD ISSUES WITH CARRYOVER FROM AN IMPROPERLY WASHED PROBE. SAMPLES WERE TESTED ON ANOTHER LYSE WASH ASSISTANT AND PRODUCED NORMAL RESULTS. THE ERRONEOUS READINGS WERE NOT REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TO MUCH CROSSOVER" "SPOKE WITH AND SHE TOLD ME THAT THE SAMPLES LOOK INCORRECT WHEN USING THE LWA. WHEN LOOKING AT SAMPLES ON ANOTHER LWA THEY ARE FINE. SHE REPLACED ALL THE FLUIDS IN THE TANKS AND ISSUE WILL NOT GO AWAY. SEEMS LIKE PROBE IS NOT BEING WASHED PROPERLY." "ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES FILL OUT CHECK LIST)? NO."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD FACS¿ LYSE WASH ASSISTANT HAD ISSUES WITH CARRYOVER FROM AN IMPROPERLY WASHED PROBE. SAMPLES WERE TESTED ON ANOTHER LYSE WASH ASSISTANT AND PRODUCED NORMAL RESULTS. THE ERRONEOUS READINGS WERE NOT REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TO MUCH CROSSOVER." "SPOKE WITH AND SHE TOLD ME THAT THE SAMPLES LOOK INCORRECT WHEN USING THE LWA. WHEN LOOKING AT SAMPLES ON ANOTHER LWA THEY ARE FINE. SHE REPLACED ALL THE FLUIDS IN THE TANKS AND ISSUE WILL NOT GO AWAY. SEEMS LIKE PROBE IS NOT BEING WASHED PROPERLY." "ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N. LEAK (IF YES FILL OUT CHECK LIST)? N."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233686 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 Unknown