BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACSCALIBUR¿

    MDR report key: 8557402 · Received April 26, 2019

    Report

    Report Number
    2916837-2019-00108
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    March 28, 2019
    Report Date
    April 23, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903429752
    PMA / PMN Number
    K973483
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SCOPE OF ISSUE: 342975 FACSCALIBUR-DAMPER/GAS SPRINGS (PN 641516) WAS DEFECTIVE AND THE LID FELL DOWN. ¿[USER] OPENED THE LID TO EDUCATE ANOTHER USER WHERE THE FLOW CELL IS AND HOW THEY CAN SEE IF THE FLOW CELL IS FILLED. [USER] OPENED THE LID 2/3 OF THE WAY (NOT FULLY OPENED) AND AT THIS POSITION THE GAS SPRINGS WERE NOT ABLE TO HOLD THE LID UP AND THE LID FELL DOWN. NO ONE WAS HARMED¿. THIS INCIDENT HAPPENED DURING USER TRAINING/EDUCATION AND NOT IN A NORMAL CLINICAL ROUTINE/SETTING OR PREVENTIVE MAINTENANCE ACTIVITIES BY USER. DEFECT TREND: QNS (ZM, ZE) RELATED TO THIS ISSUE IN SAP FROM 01MAR2018 TO 31MAR2019 = 0. THERE ARE NO RECORDED CASES OF NON-CONFORMANCES (QNS) RELATED TO CYTOMETER LIDS PIVOTING OFF OR ANY SIGNS OF PREMATURE DETERIORATION OF THE GAS SPRINGS. COMPLAINT TREND: BASED ON COMPLAINT DATA FROM 01MAR2018 TO 31MAR2019, THERE ARE 2 COMPLAINTS (742004 AND THIS COMPLAINT 875543) ON THE FACSCALIBUR LID FALLING DOWN. INVESTIGATION RESULT / ANALYSIS: UNDER SECTION 10.0 OF THE DOCUMENT 90-40619-00, ¿FACSCALIBUR MANUFACTURING CLEAN UP PROCEDURE¿¿ DESCRIBED RELEVANT LABEL PLACEMENTS, THIS INCLUDES PLACEMENT OF SERVICE LABEL, PN 95-10050-00 ON CENTER TOP LID AT THE BACK OF THE INSTRUMENT. THIS LABEL WAS CONFIRMED AVAILABLE AT THE TIME OF THE INCIDENT. THIS LABEL STATES "NO USER SERVICEABLE PARTS INSIDE. REFER TO SERVICING TO QUALIFIED PERSONNEL" ASSIGNABLE CAUSE: THE CUSTOMER OPENED THE FACSCALIBUR LID DISREGARDING THE LABEL "NO USER SERVICEABLE PARTS INSIDE. REFER TO SERVICING TO QUALIFIED PERSONNEL" RESULT OF DEVICE HISTORY RECORD (DHR) REVIEW: A REVIEW OF THE FACSCALIBUR (P/N 342975-S/N#(B)(4)) WAS CONDUCTED LAST 09APR2019. THIS INSTRUMENT WAS RELEASED FROM MANUFACTURING FLOOR LAST NOVEMBER OF YEAR 2009 WITH NO MECHANICAL ISSUES ON THE PLASTIC LID AND GAS SPRINGS AS OBSERVED IN THE DHR. NO ISSUES RELATED TO THIS FAILURE MODE WERE IDENTIFIED. RISK ANALYSIS (SOP6078-03, ¿RISK ANALYSIS¿): REVIEWED FACSCALIBUR PRODUCT FAMILY RISK MANAGEMENT FILE, 342973RA REV 07 ON 10APR2019. THE RISK ANALYSIS DOES IDENTIFY THE APPLICABLE HAZARDS RELATED TO THIS NONCONFORMANCE. RISK ASSESSMENT: RISK ANALYSIS ¿ A DOCUMENT REVIEW OF FACSCALIBUR PRODUCT FAMILY RISK MANAGEMENT FILE, 342973RA REV 03 WAS CONDUCTED ON 10APR2019. REFERENCED TO MECHANICAL HAZARD ID 1.4.1, THE INITIAL AND RESIDUAL RISK INDEX IS CHARACTERIZED TO CATEGORY 6. INITIAL RISK : PROBABILITY - 2, SEVERITY - 3, RESIDUAL INDEX - 6 INITIAL RISK EVALUATION: UNACCEPTABLE RISK CONTROLS ARE IN PLACE: THIS RISK HAS BEEN ADDRESSED AND MITIGATED THROUGH DESIGN CHANGE BY CHANGING TOP COVER FROM METAL TO A LIGHT WEIGHT PLASTIC THAT REDUCES FORCE OF IMPACT MINIMIZING THE SEVERITY OF HARM. ADD NEW CHASSIS P/N 641294. THERE WAS A PREVENTATIVE MAINTENANCE DOCUMENT UPDATE, 335956 FC FST FCB SERVICE MANUAL (REV 03) TO ROUTINELY VERIFY FUNCTIONALITY OF THE GAS SPRINGS. ANY DEFECTIVE GAS SPRING WARRANTED A PART REPLACEMENT DURING A REGULAR PM CYCLES OR SERVICE EVENTS. REFERENCE SERVICE MANUAL PN335956 REV B IN PM SECTION CHANGES NOTED ABOVE WERE IMPLEMENTED VIA CO #CO#(B)(4). RESIDUAL RISK : PROBABILITY - 2, SEVERITY - 3, RESIDUAL INDEX - 6 RESIDUAL RISK EVALUATION: AFAP, AS FAR AS POSSIBLE NEW HAZARDS: NONE CONCLUSION: THE CUSTOMER OPENED THE FACSCALIBUR LID DURING USER TRAINING/EDUCATION, DISREGARDING THE LABEL "NO USER SERVICEABLE PARTS INSIDE. REFER TO SERVICING TO QUALIFIED PERSONNEL". NO ONE WAS HARMED¿. INVESTIGATION CONCLUSION: THE CUSTOMER OPENED THE FACSCALIBUR LID DURING USER TRAINING/EDUCATION, DISREGARDING THE LABEL "NO USER SERVICEABLE PARTS INSIDE. REFER TO SERVICING TO QUALIFIED PERSONNEL". NO ONE WAS HARMED¿. REFERENCED TO PREVIOUS INCIDENT PIR#(B)(4) COMPLAINT WAS ASSOCIATED WITH PREVIOUSLY INVESTIGATED COMPLAINT AND A KNOWN ISSUE IN REFERENCE TO PIR#(B)(4). SEE REFERENCES BELOW: AE 09-02 - BD FACSCALIBUR FINGER INJURY; AE09-02 HEALTH HAZARD EVALUATION ; AE09-02 MEMORANDUM TO FILE; PIR NO. 6097 CALIBUR FINGER INJURY. BD DIRECTORY: S:\REGULATORY COMPLIANCE\POST MARKET SURVEILLANCE\ADVERSE EVENTS FY2007-2011\FY 2009\AE09-02 BD FACSCALIBUR FINGER INJURY: CPO-045, 1501-092-000-SWI, SOP 5011-18, DHR, 90-40619-00, SERVICE REPORTS, AE 09-02 - BD FACSCALIBUR FINGER INJURY, AE09-02 HEALTH HARAZD EVALUATION, E09-02 MEMORANDUM TO FILE, FCB06-06 ¿ SERVICE BULLETIN FOR FACSCALIBUR PLASTIC SKINS, FYI-05-05 ¿ GAS SPRINGS INSPECTION, PN641516 (GAS SPRING FOR PLASTIC TYPE OF FACSCALIBUR), FCB-06-01 ¿ SERVICE BULLETIN FOR TOP FRONT COVER FASTENING THIS COMPLAINT WAS CONFIRMED AS ANALYZED. NO SAMPLES WERE BEING RETAINED/PROVIDED THEREFORE UNABLE TO DRAW CONCLUSION. ALL COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: MECHANICAL FAILURE OF THE GAS SPRINGS ON A PLASTIC TYPE FACSCALIBUR LID DUE TO AGE AND USAGES. RATIONALE: BASED ON THE EVALUATION OF COMPLAINT SEVERITY S3(VIA RISK ANALYSIS, 342973RA REV 07) AND OCCURRENCE OF 2(ONE OF WHICH DID NOT CAUSE ANY HARM TO USER ¿ THIS INCIDENT) IN ONE YEAR TIME FRAME, IT WAS DETERMINED THAT THERE WAS SYSTEM IN PLACE TO CONTINUOUSLY MONITOR THE CONDITION OF THE GAS SPRINGS. ANY DEFECTIVE GAS SPRINGS ARE BEING REPLACED ONCE IDENTIFIED IN THE FIELD DURING THE PM CYCLES. ALSO WARNING LABELS LIMITING ACCESS TO THE OPENING OF THE LIDS ARE PRESENT AND AVAILABLE TO USERS. USER GUIDE MANUALS, AND SERVICE BULLETINS WERE ALSO ACCESSIBLE TO USERS TO PREVENT POTENTIAL SAFETY INCIDENTS. THIS COMPLAINT MODE WILL BE TRENDED AND FURTHER INVESTIGATION WILL BE REQUIRED IF AN ACTIONABLE LEVEL IS REACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A FACSCALIBUR¿ FLOW CYTOMETER THE USER LIFTED THE LID OF THE CYTOMETER TO EDUCATE ANOTHER USER WHERE THE FLOW CELL IS AND HOW THEY CAN SEE IF THE FLOW CELL IS FILLED. THE USER OPENED THE LID 2/3 OF THE WAY (NOT FULLY OPEN) AND AT THIS POSITION THE GAS SPRINGS WERE NOT ABLE TO HOLD THE LID UP AND THE LID FELL DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348210 FACSCALIBUR¿ FLOW CYTOMETER GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382903429752

    Patients

    Seq Age Sex Outcome Treatment
    1 Other