BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ SAMPLE PREP ASSISTANT III

    MDR report key: 16388868 · Received February 16, 2023

    Report

    Report Number
    2916837-2023-00040
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    January 4, 2023
    Report Date
    March 20, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    PER
    UDI-DI
    00382906472052
    PMA / PMN Number
    K13101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: (B)(4). PN: 647205. SPAIII SN: (B)(6). AWARENESS: 01/04/2023. OPENED: 01/04/2023. INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: 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 04JAN2022 TO DATE 04JAN2023 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 10 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 04JAN2022 TO DATE 04JAN2023 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: REPLACED THE WASTE PUMP AND INLINE FILTER. VERIFIED INSTRUMENT PERFORMANCE WITH THE PROCEDURE THAT IS PROVIDED IN THE SERVICE MANUAL. NO FURTHER ISSUES. SAMPLE PREPARATION WAS NOT AFFECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER#: WO - 02785719. INSTALL DATE: 10SEP2009. DEFECTIVE PART NUMBER: 640835-SPA INLINE FILTER KIT, 33429709-MINIWASH ASSEMBLY. WORK ORDER NOTES: SUBJECT / REPORTED: WASH TOWER IS OVERFLOWING. PROBLEM DESCRIPTION: CLOGGED/BLOCKED FLUID PATH. CAUSE: CLOGGED PUMP AND INLINE FILTER. WORK PERFORMED: REPLACED PUMP AND INLINE FILTER. SOLUTION: REPLACED PUMP AND INLINE FILTER. PARTS REPLACED: 640835-SPA INLINE FILTER KIT, 33429709-MINIWASH ASSEMBLY. RETURNED SAMPLE ANALYSIS: THE DEFECTIVE PARTS WERE NOT REQUESTED TO BE RETURNED AND NO PHOTO(S) / PICTURE(S) WERE PROVIDED. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES OR NO? HAZARD ID: 3.1.29. HAZARD: ENVIRONMENT BIOHAZARD. CAUSE: FILTER/COMPONENTS IN FLUID PATH GET CLOGGED, WASH STATION BACKS UP DUE TO WASTE PUMP FAILURE. HARMFUL EFFECTS: EXPOSURE TO BIOHAZARD. RESIDUAL SEVERITY: 5. RESIDUAL PROBABILITY: 1. RESIDUAL RISK INDEX: 5. POTENTIAL CAUSES: BASED ON THE INVESTIGATION RESULT AND FSE¿S REPORT THE POTENTIAL CAUSE WAS DETERMINED TO BE WASH PUMP AND INLINE FILTER. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR WASH TOWER OVERFLOWING. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER IS OVERFLOWING. CUSTOMER HAS ALREADY TRIED CLEANING THE INLINE FILTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER IS OVERFLOWING. CUSTOMER HAS ALREADY TRIED CLEANING THE INLINE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358997 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 Unknown