BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX40 INSTRUMENT

    MDR report key: 22631276 · Received July 28, 2025

    Report

    Report Number
    1119779-2025-02030
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 6, 2025
    Report Date
    August 1, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904422967
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THAT THE UPS IN USE WITH A BACTEC FX40 INSTRUMENT CAUGHT FIRE. A BD FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE REPLACED THE UPS, CHECKED UPS AND INSTRUMENT OPERATION AND BOTH WERE WORKING PROPERLY, ADDITIONALLY CLEANED THE AIR FILTER AND SANITIZED INSTRUMENT, AFTER WHICH THE ISSUE WAS RESOLVED. THE ROOT CAUSE IS UNKNOWN. THIS IS A CONFIRMED FAILURE OF A SPARE PART OF A BD PRODUCT. THE UPS POWERVAR MODEL: ABCE802-22 HAS BEEN DESIGNED AND MANUFACTURED IN SUCH A WAY AS TO REDUCE, AS FAR AS POSSIBLE, THE RISKS OF FIRE OR EXPLOSION DURING NORMAL USE AND IN SINGLE FAULT CONDITION. IT HAS BEEN EVALUATED TO AND MEETS THE REQUIREMENTS OF THE FOLLOWING STANDARDS: ¿ ANSI/UL 1778 (UL FILE: E122401). ¿ CSA 22.2 NOS. 107.3-14 (UL FILE: E122401). PHYSICAL SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. IF PHYSICAL SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. HOWEVER, PICTURES WERE PROVIDED. THERE IS NO DHR REVIEW BECAUSE THIS IS A SPARE PART. THERE IS NO SERVICE HISTORY BECAUSE THIS INVESTIGATION IS FOR A SPARE PART, NOT AN INSTRUMENT. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ FX40 INSTRUMENT, THE UPS CAUGHT FIRE. THERE WERE NO INJURIES OR DAMAGE TO STRUCTURES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ FX40 INSTRUMENT, THE UPS CAUGHT FIRE. THERE WERE NO INJURIES OR DAMAGE TO STRUCTURES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685198 BD BACTEC¿ FX40 INSTRUMENT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 00382904422967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown