BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LSRFORTESSA SO

    MDR report key: 10638985 · Received October 6, 2020

    Report

    Report Number
    2916837-2020-00161
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 14, 2020
    Report Date
    November 19, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. THIS INVESTIGATION WAS PERFORMED ON DEFECT TREND DATA, COMPLAINT TREND DATA, DEVICE HISTORY RECORD (DHR) REVIEW, SERVICEMAX REVIEW, AND RISK ANALYSIS (RA) REVIEW. THE FSE REPORTED THAT THE FLUID THAT LEAKED WAS SHEATH. BASED ON THE DEFECTIVE COMPONENTS (WASTE CONNECTORS, AIR PUMP, SAMPLE PRESSURE REGULATOR AND PINCH VALVE), THE DCM ASSEMBLY (P/N 64781907) FAILED. THE REPORTED COMPLAINT WAS CONFIRMED BY FSE. BASED FROM THE OBTAINED FIELD INFORMATION, HISTORICAL DATA AND PERFORMANCES, THERE HAS BEEN NO OVERALL SAFETY CONCERNS OR USER HARM/INJURY DURING THE USE OF THE DEVICE AND AFTER REPORTING THE INCIDENT. THE INSTRUMENT WAS BROUGHT BACK TO FUNCTIONAL CONDITION AFTER REPLACING 60-10013-00 - VALVE PINCH MULTI-TUBE (1X); 34465009 - PCB SAMPLE PRESSURE REGULATOR REPAIRED (1X); 02-60798-00 - ASSEMBLY PUMP (1X); 59-10091-06 - CPLN BDY PNL MT 1/16 ID WHT (2X). ROOT CAUSE: AIR COMING INTO WORN WASTE CONNECTORS CAUSING INSTABILITY AND FAILURE OF AIR PUMP, SAMPLE PRESSURE REGULATOR AND PINCH VALVE ON DCM (P/N 64781907).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD LSRFORTESSA¿ SO THE WASTE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SIP DRIPS IN MANUAL MODE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NO. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? NO. 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? NO. LIST OF PARTS SHIPPED (INCLUDE FOC): NO. RMA REQUIRED? NO. WAS THERE A FLUIDIC LEAK OR SPILL? YES. 1.WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 2. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. 3. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. 4. WHAT WAS THE FLUID THAT LEAKED/SPILLED? UNKNOWN. 5. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO.

    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 LSRFORTESSA¿ SO THE WASTE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SIP DRIPS IN MANUAL MODE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NO. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? NO. 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? NO. LIST OF PARTS SHIPPED (INCLUDE FOC): NO. RMA REQUIRED? NO WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 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? UNKNOWN. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097414 BD LSRFORTESSA SO NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other