BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ SAMPLE PREP ASSISTANT III

    MDR report key: 15476271 · Received September 24, 2022

    Report

    Report Number
    2916837-2022-00267
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    September 14, 2022
    Report Date
    December 5, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    PER
    UDI-DI
    00382906472052
    PMA / PMN Number
    K131301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY (B)(4) PN: 647205 SPAIII SN: (B)(6) AWARENESS: 09/14/2022 OPENED: 09/14/2022 INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6) ¿ PROBLEM STATEMENT: CUSTOMER REPORTED: A LEAK IN THE BACK OF THE REAGENTS ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 14SEP2021 TO DATE 14SEP2022 (ROLLING 12 MONTHS) ¿ COMPLAINT TREND: THERE ARE 8 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 14SEP2021 TO DATE 14SEP2022 (ROLLING 12 MONTHS) O COMPLAINT DATA ATTACHED ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: A MALFUNCTION WAS DETECTED IN THE FLUIDIC AREA OF THE SPA III. REPLACING THE 59-10181-05 FITTING ALONG THE EXHAUST FLUID LINE RESOLVED THE MALFUNCTION. CHECKED THAT THE INSTRUMENT IS WORKING PROPERLY, SAMPLE PREPARATION TEST PERFORMED WITH POSITIVE RESULT. O NO FURTHER ISSUES O SAMPLE PREPARATION WAS NOT AFFECTED. O THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER#(B)(4) INSTALL DATE: (B)(6) 2016 DEFECTIVE PART NUMBER: 59-10181-05 ¿ CPLN BODY PNL MT WORK ORDER NOTES: O SUBJECT / REPORTED: A LEAK IN THE BACK OF THE REAGENTS O PROBLEM DESCRIPTION: FLUIDIC LEAK O CAUSE: DEFECTIVE/DAMAGED COUPLING/CONNECTOR O WORK PERFORMED: REPLACE COUPLING/CONNECTOR O SOLUTION: REPLACED COUPLING/CONNECTOR O PARTS REPLACED: COUPLING BODY PANEL MOUNT ¿ RETURNED SAMPLE ANALYSIS: DID NOT REQUEST RETURN OF DEFECTIVE PART ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: X0453 AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ RISK ANALYSIS: O RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES NO HAZARD ID: 3.1.28 HAZARD: ENVIRONMENT BIOHAZARD CAUSE: LEAKING WASTE/FLUIDIC LINES HARMFUL EFFECTS: EXPOSURE TO BIOHAZARD RESIDUAL SEVERITY: 5 RESIDUAL PROBABILITY: 1 RESIDUAL RISK INDEX: 5 O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__ O RISK CONTROL:_AFAP_____ O MITIGATION(S) SUFFICIENT YES NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND FSE'S REPORT THE ROOT CAUSE WAS A DEFECTIVE COUPLING/CONNECTOR ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR A LEAK IN THE BACK OF THE REAGENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS A LEAK IN THE BACK OF THE REAGENTS, PROBABLY FROM THE WASTE TUBE. LEAKAGE CONTAINED WITHIN THE INSTRUMENT IN A CUSTOMER ACCESSIBLE LOCATION. LEAKED FLUID: SHEATH FLUID. THE SOURCE WAS NON-WASTE LINE. CUSTOMER WAS NOT EXPOSED TO BLOOD OR BODILY FLUIDS. THE CUSTOMER SUFFERED NO PHYSICAL HARM AS R... THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A LEAK IN THE BACK OF THE REAGENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS A LEAK IN THE BACK OF THE REAGENTS, PROBABLY FROM THE WASTE TUBE. LEAKAGE CONTAINED WITHIN THE INSTRUMENT IN A CUSTOMER ACCESSIBLE LOCATION. LEAKED FLUID: SHEATH FLUID. THE SOURCE WAS NON-WASTE LINE. CUSTOMER WAS NOT EXPOSED TO BLOOD OR BODILY FLUIDS. THE CUSTOMER SUFFERED NO PHYSICAL HARM AS R. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A LEAK IN THE BACK OF THE REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588150 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