BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS SAMPLE PREP ASSISTANT III

    MDR report key: 10352038 · Received July 31, 2020

    Report

    Report Number
    2916837-2020-00072
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 9, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    PER
    UDI-DI
    00382906472052
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ PROBLEM STATEMENT: CUSTOMER REPORTED THAT THE SPA WASH TOWER IS OVERFLOWING ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 09JUL2019 TO DATE 09JUL2020 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE 5 OF COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 09JUL2019 TO DATE 09JUL2020 (ROLLING 12 MONTHS). ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE FSE REPORT VERIFIED ISSUE WITH WASH STATION PUMP. MINI WASH ASSEMBLY WAS REPLACED. SYSTEM PASSED ALL REQUIRED TESTS. SPA WAS RETURNED TO LAB FOR NORMAL USE. NO ONE WAS EXPOSED TO ANY BIOLOGICAL HAZARDS OR BODILY FLUIDS. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #01528661__. INSTALL DATE: (B)(6) 2009__________. DEFECTIVE PART NUMBER: 334297________. WORK ORDER NOTES: O SUBJECT / REPORTED: WASH STATION OVERFLOWING. O PROBLEM DESCRIPTION: WASH STATION WAS OVERFLOWING. O CAUSE: WASH STATION PUMP FAILURE. O WORK PERFORMED: REPLACED MINIWASH STATION. O SOLUTION: REPLACE MINIWASH STATION. ¿ RETURNED SAMPLE EVALUATION: FSE RESOLVED THE ISSUE BY REPLACING THE MINIWASH STATION . ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: X0007 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES NO. O HAZARD ID: 3.1.29 _. O HAZARD: ENVIRONMENTAL BIOHAZARD. O SEVERITY: 5. O PROBABILITY: 1. O RISK INDEX: 5. O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__. O RISK CONTROL:_ALARP_____. MITIGATION(S) SUFFICIENT YES NO. ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE WAS THE WASTE PUMP WAS DEFECTIVE. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WASTE IS OVERFLOWING FROM WASH TOWER WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH TOWER IS OVERFLOWING. ADDITIONALLY, ON 2020-7-9 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTS THAT THE WASH TOWER IS OVERFLOWING AGAIN. SHE REPLACED THE INLINE FILTER BUT THAT DID NOT RESOLVE THE ISSUE. THE INSTRUMENT HAS BEEN PLACED DOWN AND OUT OF SERVICE. NEXT STEPS (IF NECESSARY): DISPATCHING THE CALL. 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 RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? NO. SOFTWARE VERSION? NA. LIST OF PARTS SHIPPED (INCLUDE FOC): NA. RMA REQUIRED? NA. WAS THERE A FLUIDIC LEAK OR SPILL? YES. 1. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. 3. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE. 4. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. ADDITIONALLY, ON 2020-07-17 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: LEAK WAS BEFORE WASTE TANK, THUS WASTE WAS NOT MIXED WITH BLEACH OR A DECONTAMINATE.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WASTE IS OVERFLOWING FROM WASH TOWER WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH TOWER IS OVERFLOWING. ADDITIONALLY, ON 2020-7-9 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTS THAT THE WASH TOWER IS OVERFLOWING AGAIN. SHE REPLACED THE INLINE FILTER BUT THAT DID NOT RESOLVE THE ISSUE. THE INSTRUMENT HAS BEEN PLACED DOWN AND OUT OF SERVICE. NEXT STEPS (IF NECESSARY): DISPATCHING THE CALL. 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. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? NO. SOFTWARE VERSION? NA. LIST OF PARTS SHIPPED (INCLUDE FOC): NA. RMA REQUIRED? NA. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. ADDITIONALLY, ON 2020-07-17 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: LEAK WAS BEFORE WASTE TANK, THUS WASTE WAS NOT MIXED WITH BLEACH OR A DECONTAMINATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812690 BD FACS SAMPLE PREP ASSISTANT III SEE H.10 PER BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 647205 00382906472052

    Patients

    Seq Age Sex Outcome Treatment
    1 Other