BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ARIA !!! 3B/2R/2V/4YG

    MDR report key: 10442713 · Received August 24, 2020

    Report

    Report Number
    2916837-2020-00093
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    August 3, 2020
    Report Date
    October 14, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON AN ARIA III 3B/2R/2V/4YG ACDU BASIC ¿ 64828223 OF WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED (OUTSIDE INSTRUMENT). ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 03AUG2019 TO DATE 03AUG2020. ¿ COMPLAINT TREND: THIS IS THE ONLY COMPLAINT RELATED TO THE ISSUE OF WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED (OUTSIDE INSTRUMENT). DATE RANGE FROM 03AUG2019 TO DATE 03AUG2020. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 64828223 SERIAL # (B)(6), FILE# (B)(6), 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 THAT WAS NOT CONTAINED WITHIN THE ARIA III INSTRUMENT WAS DUE TO A WORN CONNECTOR/COUPLING ON THE WASTE LINE. THIS COUPLING IS LOCATED ON THE OUTSIDE PANEL OF THE INSTRUMENT AND CONNECTS THE WASTE LINE TO THE TANK. THE SOURCE OF THE LEAK WAS CONFIRMED BY FSE (FIELD SERVICE ENGINEER) AND ALSO FOUND THAT IT DAMAGED THE CHANNEL A PREAMP BOARD ON THE UV TRIGON. THE FSE REPLACED PARTS 64147827 - PCB ASSEMBLY PRE AMP ARIA II SVC, 343530 - FILTER CONNECTOR/MALE COUPLING AND 59-10092-05 - CPLN BDY PANL MT 1/8 JD ORG TO RESOLVE THE ISSUE. THESE PARTS WERE FROM NON-INVENTORIED STOCK AND ARE NOT RETURNABLE FOR EVALUATION, THEREFORE WERE DISCARDED. AFTER THE REPAIRS, THE INSTRUMENT WAS OPERATING NORMALLY WITHOUT LEAKS. ALTHOUGH THE LEAK WAS WASTE AND THE POTENTIAL EXPOSURE TO BIOHAZARD MATERIAL, THERE WAS NO SKIN CONTACT NOR WAS THERE ANY MEDICAL TREATMENT PERFORMED. NO USER WAS HARMED OR INJURED. USERS SHOULD WEAR PROPER PPE (PERSONAL PROTECTIVE EQUIPMENT) ESPECIALLY HANDLING BIOLOGICAL WASTE, AS CAUTIONED THROUGHOUT THE USER GUIDE; BD FACSARIA¿ III USER¿S GUIDE - #23-19938-02, STARTING ON PAGE 141. AFTER THE REPAIRS, THE INSTRUMENT WAS REBOOTED, TESTED AND IS FUNCTIONING AS EXPECTED. THE SAFETY RISK IS SEVERE, S4, HOWEVER THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 01555811, CASE # (B)(6). INSTALL DATE: (B)(6) 2013. DEFECTIVE PART NUMBER: O 64147827 - PCB ASSEMBLY PRE AMP ARIA II SVC. O 343530 - FILTER CONNECTOR/MALE COUPLING. O 59-10092-05 - CPLN BDY PANL MT 1/8 JD ORG. WORK ORDER NOTES: O SUBJECT / REPORTED: LEAKING FLUID, POSSIBLY ETHANOL OR PPS. O PROBLEM DESCRIPTION: LEAKING FLUID, POSSIBLY ETHANOL OR PPS. O WORK PERFORMED: FOUND THE LEAK SOURCE ON THE COUPLING ON THE INSTRUMENT CONNECTED TO OUTSIDE WASTE LINE. REPLACED THE COUPLING CONNECTOR. THE LEAK DAMAGED THE CHANNEL A PREAMP BOARD ON THE UV TRIGON. REPLACED THE BOARD. TESTED SYSTEM, NO LEAK. RUN BEADS, ALL PARAMETERS AND SIGNALS ARE WORKING FINE. PASSED CST. SYSTEM IS OPERATIONAL AND READY TO USE. O CAUSE: BROKEN FITTING FROM WASTE LINE. O SOLUTION: AS ABOVE. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE REPLACED PARTS ARE NOT RETURNABLE AND WAS DISCARDED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART #648282RA, VERSION 08 / REVISION H - FACS ARIA PRODUCT FAMILY RISK ANALYSIS WAS REVIEWED. NO NEW HAZARD HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES NO. O HAZARD ID: 2.1.3. O HAZARD: USER EXPOSURE TO BIOHAZARD. O CAUSE: WASTE TANK LEAK. O HARMFUL EFFECTS: USER EXPOSED TO BIOHAZARD MAY GET INFECTED. O RISK CONTROL: . - HANDLE PROVIDED ON TANK. - BLEACH ADDED TO TANK. O IMPLEMENTATION VERIFICATION: - TANK BD P/N 340261. - ARIA USERS GUIDE. O EFFECTIVENESS VERIFICATION: - USER¿S GUIDE - SAFETY MANUAL. O PROBABILITY: 2. O SEVERITY: 4. O RISK INDEX: 8. O RESIDUAL RISK EVALUATION: ALARP. O NEW HAZARD: NONE. O HAZARD ID: 2.1.4. O HAZARD: USER EXPOSURE TO BIOHAZARD. O CAUSE: FILTER CLOGS OR BECOMES WET - CUSTOMER DOESN¿T CHANGE FILTER IN A TIMELY MANNER. O HARMFUL EFFECTS: USER EXPOSED TO BIOHAZARD MAY GET INFECTED. O RISK CONTROL: 1. FILTER ON WASTE CAP IS MADE UP OF FOUR FILTERS. 2. LABEL TO ON CAPS ALLOWS USERS TO WRITE IN DATE INDICATING WHEN FILTER WAS LAST CHANGED. 3. BAFFLE. 4. USER¿S GUIDE INDICATES TO CHANGE CAPS MONTHLY. O IMPLEMENTATION VERIFICATION: - SEE DESIGN REVIEW FOR PCA II ¿ ARIA DHF. - SAFETY MANUAL. - USER¿S GUIDE. O EFFECTIVENESS VERIFICATION: LABEL APPROVAL. O PROBABILITY: 2. O SEVERITY: 4. O RISK INDEX: 8. O RESIDUAL RISK EVALUATION: ALARP. O NEW HAZARD: NONE. MITIGATION(S) SUFFICIENT YES. NO. ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAK WAS DUE TO A WORN WASTE COUPLING CONNECTER. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF WASTE LEAKAGE NOT CONTAINED WITHIN THE ARIA III INSTRUMENT WAS DUE TO A WORN WASTE COUPLING CONNECTOR. THE FSE HAD CONFIRMED THE ISSUE AND PERFORMED ALL THE REPAIRS TO RESOLVE THEM. AFTER THE REPAIRS, THE INSTRUMENT WAS TESTED, AND WAS FUNCTIONING AS EXPECTED. THE USER WAS WEARING PROPER PPE AND THERE WAS NO DIRECT CONTACT TO BIOLOGICAL FLUIDS NOR WAS THERE HARM OR INJURY. ALTHOUGH THE SAFETY RISK LEVEL IS SEVERE, S4, THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT DURING USE WITH A BD ARIA¿ !!! 3B/2R/2V/4YG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING FLUID, POSSIBLY ETHANOL OR PPS. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? FACSFLOW MIXED WITH WASTE , BEFORE RUNNING SAMPLES. 5. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS?NO, LEAK HAPPENED IN STARTUP BEFORE RUNNING ANY SAMPLES. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO¿

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT DURING USE WITH A BD ARIA¿ !!! 3B/2R/2V/4YG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING FLUID, POSSIBLY ETHANOL OR PPS. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? FACSFLOW MIXED WITH WASTE, BEFORE RUNNING SAMPLES WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO, LEAK HAPPENED IN STARTUP BEFORE RUNNING ANY SAMPLES. 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
    911062 BD ARIA !!! 3B/2R/2V/4YG NA GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other