BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO II

    MDR report key: 10549979 · Received September 17, 2020

    Report

    Report Number
    2916837-2020-00123
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 11, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382903389629
    PMA / PMN Number
    K141468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO PART # 338962 AND SERIAL #: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON A BD FACSCANTO II CYTOMETER 4/2/2 SYS IVD ¿ 338962 THAT LEAKAGE OF BIOHAZARD, WITHOUT BLEACH, WAS NOT CONTAINED WITHIN THE WET CART INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 11AUG2019 TO DATE 11AUG2020. COMPLAINT TREND: THERE ARE 4 COMPLAINTS RELATED TO THIS ISSUE OF A WASTE LEAKING UNDERNEATH THE WET CART WITHOUT BLEACH; PR# (B)(4) AND THIS ONE, 1746007. DATE RANGE FROM 11AUG2019 TO DATE 11AUG2020. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF DHR PART # 338962 SERIAL # V96300575 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, AND RISK ANALYSIS, THE ROOT CAUSE OF THE WASTE LEAK FOUND UNDER THE WET CART WAS DUE TO A CRACK FOUND IN FLUIDIC MANIFOLD WHERE ALL THE LIQUID LINES CONNECT. THE LOCATION OF THE SOURCE OF THE LEAK IS BEFORE THE WASTE TANK SO IT WAS NOT MIXED WITH BLEACH. THE LEAK AFFECTED ADDITIONAL PARTS THAT DEVELOPED CORROSION LIKE ON THE CONNECTION OF THE WASTE P3 PUMP CAUSING IT TO STOP WORKING AND NOT ASPIRATE. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THE ROOT CAUSE AND REPLACED BOTH THE FLUIDIC MANIFOLD, 644254 - MANIFOLD LL3VM2 WETCART, AND THE DAMAGED PUMP. BOTH ITEMS ARE FROM NON-INVENTORIED STOCK AND NOT RETURNABLE, THEREFORE WERE DISCARDED. AFTER PERFORMING THE REPAIRS AND RUNNING TESTS THE FSE FOUND NO LEAKS AND THE INSTRUMENT WAS RUNNING AS EXPECTED. ALTHOUGH THE LEAK WAS WASTE AND POTENTIAL EXPOSURE TO BIOHAZARD MATERIAL, THERE WAS NO SKIN CONTACT NOR WAS THERE ANY MEDICAL TREATMENT PERFORMED. NO USER WAS HARMED OR INJURED AS THEY WERE WEARING PROPER PPE (PERSONAL PROTECTIVE EQUIPMENT). BD FACSCANTO II INSTRUCTIONS FOR USE (IFU), #23-20269-00, INDICATES TO WEAR SUITABLE PROTECTIVE CLOTHING AND GLOVES TO PREVENT TRANSMISSION OF POTENTIAL FATAL DISEASE FROM BIOLOGICAL SPECIMENS. AFTER THE REPAIRS, THE INSTRUMENT WAS REBOOTED, TESTED AND FUNCTIONING AS EXPECTED. THE SAFETY RISK IS LOW AS THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK IS WASTE, IT WAS NOT CONTAINED WITHIN INSTRUMENT, NO RESULTS AFFECTED, NO-ONE HURT.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH A BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK IS WASTE, IT WAS NOT CONTAINED WITHIN INSTRUMENT, NO RESULTS AFFECTED, NO-ONE HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016209 BD FACSCANTO II COUNTER, DIFFERENTIAL CELL OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 338962 NA 00382903389629

    Patients

    Seq Age Sex Outcome Treatment
    1 Other