BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACSCANTO IVD 10 COLOR CONFIGURATION

    MDR report key: 12748785 · Received November 3, 2021

    Report

    Report Number
    2916837-2021-00424
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 7, 2021
    Report Date
    January 5, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906573384
    PMA / PMN Number
    K141468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSCANTO IVD 10 COLOR CONFIGURATION, PART # 657338 AND SERIAL # (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING SAMPLE CARRYOVER. ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 07OCT2020 TO DATE 07OCT2021. ¿ COMPLAINT TREND: THE ONLY COMPLAINT RELATED TO THE ISSUE OF SAMPLE CARRYOVER FOR THIS PART NUMBER WITHIN THE DATE RANGE IS THIS ONE. DATE RANGE FROM 07OCT2020 TO DATE 07OCT2021. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 657338, 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 A BLOCKAGE IN THE SIT. THE CUSTOMER HAD INITIALLY REPORTED A CARRYOVER OF 0.22%. THE FSE (FIELD SERVICE ENGINEER) RESPONDING TO THE ISSUE OBSERVED THE INSTRUMENT AND VERIFIED THAT THE SIT FLUSH VALVE WAS FUNCTIONING PROPERLY. THEY THEN REPLACED THE SIT FLUSH TUBING AND BACK FLUSHED THE SIT WITH A SYRINGE. AFTER THESE REPAIRS THE CUSTOMER RAN CARRYOVER TESTS AND CONFIRMED THAT THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. WHILE THIS INSTRUMENT WAS BEING USED FOR CLINICAL TREATMENT, THE CUSTOMER CONFIRMED THAT THE RESULTS GATHERED DURING THIS INCIDENT WERE NOT USED AND DID NOT AFFECT OR DELAY THE TREATMENT OF ANY PATIENTS. PROPER DAILY AND MONTHLY CLEANING AND MAINTENANCE CAN HELP PREVENT BLOCKAGES WITHIN THE FLUIDICS SYSTEM, AND CAN BE FOUND IN THE ¿MAINTENANCE¿ SECTION OF THE BD FACSCANTO¿ II FLOW CYTOMETER INSTRUCTIONS FOR USE (IFU) MANUAL, #23-20269-00 REV. 1/VERS. A. THE SAFETY RISK IS LIMITED, S2, 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: 09SEP2016. DEFECTIVE PART NUMBER: 343666 - TUBING SILICONE .030IN ID X.082IN. WORK ORDER NOTES: O SUBJECT / REPORTED: CARRY OVER ISSUE, MEASURED AT .22%. O PROBLEM DESCRIPTION: CARRY OVER ISSUE, MEASURED AT .22%. FSE IS AWARE OF THE ISSUE. O WORK PERFORMED: VERIFIED PROPER OPERATION OF SIT FLUSH VALVE. REPLACED FLUSH TUBING. BACK FLUSHED SIT WITH A SYRINGE. CUSTOMER RAN CARRYOVER TEST AN ALL PASSED. 10/18 CHECKED BAC AND CARRYOVER ISSUE HAS NOT RETURNED CLOSED CALL. O CAUSE: OBSTRUCTION IN SIT FLUSH PATH. O SOLUTION: WILL LEAVE CALL OPEN AND MONITOR FOR A COUPLE WEEKS. IF ISSUE RETURNS SIT WILL BE REPLACED. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO REPLACED PARTS. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART #(B)(4), VERSION A, BD FACSCANTO FLUIDICS RISK ANALYSIS WAS REVIEWED. THE SEVERITY RATING IN THIS FILE IS A ¿2¿ AND THE RPN IS ¿70" BASED ON THE PREVIOUS SCALE RATING. THIS RATING IS EQUIVALENT TO ¿S2¿ IN (B)(4) REV. 12/VERS. J, WHEREBY THE UNEXPECTED RESULT IS OBVIOUS OR INDICATED BY ADDITIONAL (WARNING) INFORMATION AND HENCE THE IMPACT TO THE PATIENT IS NEGLIGIBLE TO NONE. THE CURRENT MITIGATIONS ARE ADEQUATE WITH RPN UNDER ACCEPTABLE RANGE. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES NO. O ITEM: 10 SIT ID/OD FLUSH. O FUNCTION: 10.1 CLEAN SIE ID/OD, REDUCE CARRYOVER. O POTENTIAL FAILURE MODE: 10.1.1 SALINE DROP HANGS ON END OF SIT AFTER PURGE CYCLE. O POTENTIAL EFFECTS OF FAILURE: 10.1.1.1 DROP ENTERS NEXT SAMPLE AND DILUTES IT; EVENT RATE DROPS. O POTENTIAL CAUSES/MECHANISMS OF FAILURE: DROP STUCK TO SIT. O CURRENT CONTROLS: USER OBSERVATION OF EVENT RATE. O RECOMMENDED ACTIONS: WARN ABOUT EFFECT IN USER¿S GUIDE. O SEV: 2. O OCC: 5. O DET: 7. O RPN: 70. MITIGATION(S) SUFFICIENT YES NO. ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE CARRYOVER BETWEEN SAMPLE TESTS WAS DUE TO A BLOCKAGE IN THE SIT. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE CARRYOVER BETWEEN SAMPLE TESTS WAS DUE TO A BLOCKAGE IN THE SIT. THE FSE CONFIRMED THE ISSUE AND STARTED THE REPAIR BY VERIFYING THAT THE SIT FLUSH VALVE WAS FUNCTIONAL. THEY THEN REPLACED THE SIT FLUSH TUBING AND REMOVED THE SIT CLOG WITH A SYRINGE. THE INSTRUMENT WAS THEN TESTED BY THE CUSTOMER AND CONFIRMED TO BE FUNCTIONING AS EXPECTED. NO TREATMENT OR DIAGNOSIS WAS GIVEN DUE TO THE UNEXPECTED RESULTS. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING FACSCANTO IVD 10 COLOR CONFIGURATION HAD A CARRYOVER ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLES CHECKLIST FROM WO. 1) ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. IT WAS REPORTED THAT THERE WAS A CARRY OVER ISSUE. IS INSTRUMENT ASSURITY LINC ENABLED? N. CUSTOMER PROBLEM: CARRY OVER ISSUE, MEASURED AT .22%. FSE IS AWARE OF THE ISSUE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NONE. NEXT STEPS (IF NECESSARY): DISPATCHING CASE AT CUSTOMERS REQUEST. 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 EXPLAIN)? N. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? N/A. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? N/A. 3. WHAT WAS THE FLUID THAT LEAKED? N/A. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? N/A. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N/A. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK N/A. SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? N. FOLLOW UP REQUIRED (Y/N)? Y. LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED (Y/N)? N/A. (B)(6) : 2021-10-07 12:28:27 (GMT) CARRY OVER ISSUE, MEASURED AT .22%. FSE IS AWARE OF THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING FACSCANTO IVD 10 COLOR CONFIGURATION HAD A CARRYOVER ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLES CHECKLIST FROM WO 1) ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. IT WAS REPORTED THAT THERE WAS A CARRY OVER ISSUE. IS INSTRUMENT ASSURITY LINC ENABLED? N. CUSTOMER PROBLEM: CARRY OVER ISSUE, MEASURED AT .22%. FSE IS AWARE OF THE ISSUE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NONE. NEXT STEPS (IF NECESSARY): DISPATCHING CASE AT CUSTOMERS REQUEST. 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 EXPLAIN)? N. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? N/A. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? N/A. 3. WHAT WAS THE FLUID THAT LEAKED? N/A. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? N/A. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N/A. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK N/A. SOFTWARE VERSION? UNKNOWN RESOLUTION ACHIEVED (Y/N)? N. FOLLOW UP REQUIRED (Y/N)? Y. LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED (Y/N)? N/A. (B)(4). CARRY OVER ISSUE, MEASURED AT .22%. FSE IS AWARE OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647625 FACSCANTO IVD 10 COLOR CONFIGURATION COUNTER, DIFFERENTIAL CELL OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 657338 NA 00382906573384

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown