BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18936551 · Received March 19, 2024

    Report

    Report Number
    0002937457-2024-00467
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    March 16, 2024
    Report Date
    April 15, 2024
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861102112
    PMA / PMN Number
    K173972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE ACTUAL DEVICE 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. INSTALL THE POWER SUPPLY (AS-RECEIVED CONDITION) ONTO A TEST MACHINE FOR TESTING. THE MACHINE WAS UNABLE TO POWER UP. POWER CONTROL BOARD WAS REPLACED FOR RETESTING. DIALYSIS MODE FUNCTIONED PROPERLY WITHOUT ANY FAILURES. NO PROBLEMS DURING POWER UP. DIALYSIS MODE FUNCTIONED PROPERLY WITHOUT ANY FAILURES. A SELF-TEST PROGRAM COMPLETED WITHOUT ANY FAILURES. FURTHER INSPECTION FOUND DAMAGE AND LIFT TRACES AROUND RV1 AREA. THE POWER CONTROL BOARD IS NOT REPAIRABLE. NO FURTHER TESTING CAN BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE DUE TO DAMAGED TRACES ON THE BOARD.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A USER FACILITY REPORTED A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD THERMAL DECOMPOSITION OF THE POWER SUPPLY. A FIELD SERVICE TECHNICIAN (FST) REPLACED THE POWER SUPPLY. UPON FOLLOW-UP, THE BIOMEDICAL TECHNICIAN (BMT) STATED A BURNING SMELL WAS NOTED AND THE MACHINE BEGAN SMOKING WHEN THE MACHINE WAS TURNED ON AND WAS IMMEDIATELY TURNED OFF. PER BMT THE POWER CONTROL BOARD WITHIN THE POWER SUPPLY APPEARED BURNT. THE BMT CONFIRMED THE SMOKE DETECTORS WERE NOT TRIGGERED. THE BMT REPORTED THERE WAS NO SPARK OR FLAME OBSERVED. THE POWER SUPPLY WAS NOTICED DURING ANNUAL INSPECTION PREVENTATIVE MAINTENANCE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. PER BMT THE POWER SUPPLY WAS REPLACED BY THE FST AND THE ISSUE WAS RESOLVED. THE BMT REPORTED THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT REOCCURRENCE OF THE EVENT. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 781 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPORTED THAT THE POWER SUPPLY COMPONENT WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD THERMAL DECOMPOSITION OF THE POWER SUPPLY. A FIELD SERVICE TECHNICIAN (FST) REPLACED THE POWER SUPPLY. UPON FOLLOW-UP, THE BIOMEDICAL TECHNICIAN (BMT) STATED A BURNING SMELL WAS NOTED AND THE MACHINE BEGAN SMOKING WHEN THE MACHINE WAS TURNED ON AND WAS IMMEDIATELY TURNED OFF. PER BMT THE POWER CONTROL BOARD WITHIN THE POWER SUPPLY APPEARED BURNT. THE BMT CONFIRMED THE SMOKE DETECTORS WERE NOT TRIGGERED. THE BMT REPORTED THERE WAS NO SPARK OR FLAME OBSERVED. THE POWER SUPPLY WAS NOTICED DURING ANNUAL INSPECTION PREVENTATIVE MAINTENANCE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. PER BMT THE POWER SUPPLY WAS REPLACED BY THE FST AND THE ISSUE WAS RESOLVED. THE BMT REPORTED THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT REOCCURRENCE OF THE EVENT. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 781 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPORTED THAT THE POWER SUPPLY COMPONENT WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537047 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