BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HD SYS. W/O CDX W/BIBAG BLUE STAR

    MDR report key: 19352580 · Received May 20, 2024

    Report

    Report Number
    0002937457-2024-00791
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 17, 2024
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861102112
    PMA / PMN Number
    K173972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL INSPECTION OF THE RETURNED POWER SUPPLY FOUND THERMAL DAMAGE TO VARISTOR (RV1) AND SOOT ON THE BACK OF THE POWER CONTROL BOARD (P/N 190937). THERE IS NO OTHER DAMAGE FOUND ON THE POWER CONTROL BOARD, AND POWER SUPPLY. THE POWER SUPPLY WAS INSTALLED (IN AS-RECEIVED CONDITION) ONTO A TEST MACHINE FOR TESTING. NO PROBLEMS WERE ENCOUNTERED DURING THE INITIAL POWER UP. DIALYSIS MODE FUNCTIONED PROPERLY WITHOUT ANY FAILURES. A SELF-TEST PROGRAM COMPLETED WITHOUT ANY FAILURES. VARISTOR (RV1) WAS REPLACED ON THE POWER CONTROL BOARD FOR RETESTING. NO PROBLEMS WERE ENCOUNTERED DURING POWER UP. DIALYSIS MODE FUNCTIONED PROPERLY WITHOUT ANY FAILURES. A SELF-TEST PROGRAM COMPLETED WITHOUT ANY FAILURES. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 0

    A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AFTER A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A 2008T MACHINE CAUGHT ON FIRE AND PRODUCED SMOKE AND BLACK SOOT WAS IDENTIFIED WITHIN THE CARD CAGE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED AND FST. THE STAFF REPORTED TO THE BIOMED THAT A FLAME WAS VISUALLY OBSERVED COMING FROM THE VENT OF THE 2008T MACHINE THAT TURNED INTO BLACK SMOKE. THE BIOMED STATED THAT THE REPORTED EVENT OCCURRED WHILE THE MACHINE POWERED OFF BUT PLUGGED INTO THE WALL OUTLET. THE MACHINE WAS UNPLUGGED FROM THE WALL OUTLET AND THE SMOKE WAS BLOWN AWAY TO RESOLVE THE REPORTED ISSUE. THE FIRE AND SMOKE COMING FROM THE MACHINE DID NOT TRIGGER THE FACILITY SMOKE DETECTORS. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED CONFIRMED THAT THE MACHINE HAS APPROXIMATELY 1,029 HOURS AND THAT THE POWER SUPPLY IS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED STATED THAT THE POWER SUPPLY WAS REPLACED, WHICH RESOLVED THE MACHINE ISSUE, AND THAT THE MACHINE IS BACK IN SERVICE WITHOUT ANY ISSUES. THE FST STATED THAT UPON EVALUATION BLACK SOOT WAS VISUALLY CONFIRMED WITHIN THE CARD CAGE OF THE 2008T MACHINE. THE FST STATED NOTED A BLOWN CAPACITOR ON THE POWER CONTROL BOARD OF THE POWER SUPPLY. THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE POWER SUPPLY. THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Description of Event or Problem · 0

    A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AFTER A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A 2008T MACHINE CAUGHT ON FIRE AND PRODUCED SMOKE AND BLACK SOOT WAS IDENTIFIED WITHIN THE CARD CAGE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED AND FST. THE STAFF REPORTED TO THE BIOMED THAT A FLAME WAS VISUALLY OBSERVED COMING FROM THE VENT OF THE 2008T MACHINE THAT TURNED INTO BLACK SMOKE. THE BIOMED STATED THAT THE REPORTED EVENT OCCURRED WHILE THE MACHINE POWERED OFF BUT PLUGGED INTO THE WALL OUTLET. THE MACHINE WAS UNPLUGGED FROM THE WALL OUTLET AND THE SMOKE WAS BLOWN AWAY TO RESOLVE THE REPORTED ISSUE. THE FIRE AND SMOKE COMING FROM THE MACHINE DID NOT TRIGGER THE FACILITY SMOKE DETECTORS. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED CONFIRMED THAT THE MACHINE HAS APPROXIMATELY 1,029 HOURS AND THAT THE POWER SUPPLY IS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED STATED THAT THE POWER SUPPLY WAS REPLACED, WHICH RESOLVED THE MACHINE ISSUE, AND THAT THE MACHINE IS BACK IN SERVICE WITHOUT ANY ISSUES. THE FST STATED THAT UPON EVALUATION BLACK SOOT WAS VISUALLY CONFIRMED WITHIN THE CARD CAGE OF THE 2008T MACHINE. THE FST STATED NOTED A BLOWN CAPACITOR ON THE POWER CONTROL BOARD OF THE POWER SUPPLY. THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE POWER SUPPLY. THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161609 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 00840861102112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown