BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T

    MDR report key: 7044335 · Received November 20, 2017

    Report

    Report Number
    2937457-2017-01208
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 23, 2017
    Report Date
    December 4, 2017
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861100897
    PMA / PMN Number
    K093902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO THE DHR REVIEW CHECKLIST AND RELEASE PROCEDURE. A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. IN ADDITION, THE DEVICE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED A FIRE IN THE CARD CAGE THAT DAMAGED THE ACTUATOR/TEST BOARD, FUNCTION BOARD, USB1 CABLE P/N 190717, RS-232 CABLE AND THE ACTUATOR CABLE. THE BIOMED TECH STATED HE WAS TROUBLESHOOTING A LOW FLOW ERROR MESSAGE WHEN HE SMELLED A BURNING SMELL FROM THE CARD CAGE FOR ABOUT ONE MINUTE. NO AUDIBLE ALARMS WERE NOTED OR EXPECTED BECAUSE THE DIALYSATE LINES WERE ON THE SHUNT. THE MACHINE CONTINUED RUNNING AND HE COMPLETED A HEAT DISINFECT BEFORE TURNING IT OFF. THE NEXT MORNING THE STAFF TURNED THE MACHINE ON AND IT GAVE A FAILED SENDING DATA TO ACTUATOR BOARD MESSAGE. THE CARD CAGE WAS OPENED TO TROUBLESHOOT AND THE BIOMED TECH REPORTED SIGNS OF THE FIRE. THERE WAS DAMAGE TO THE BOARDS AND CABLES AND BLACK SOOT INDICATING THAT THERE HAD BEEN A FIRE. NO FLAMES OR SMOKE WERE NOTED, AND ONLY A SHORT BURNING SMELL WAS REPORTED. ADDITIONAL FOLLOW-UP WITH THE BIOMED TECH REVEALED DIODE 19 AND THE DRIVER IC BELOW IT WERE BURNT ON THE ACTUATOR BOARD. THE BIOMED TECH REPORTED HE HAD PERFORMED A PM ON THIS MACHINE AND REBUILT THE DEAERATION MOTOR, AND THE INCIDENT OCCURRED AFTER THE BIOMED TECH INSTALLED THE MOTOR AND RAN THE MACHINE. COMPONENTS WERE AVAILABLE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED A FIRE IN THE CARD CAGE THAT DAMAGED THE ACTUATOR/TEST BOARD, FUNCTION BOARD, USB1 CABLE P/N 190717, RS-232 CABLE AND THE ACTUATOR CABLE. THE BIOMED TECH STATED HE WAS TROUBLESHOOTING A LOW FLOW ERROR MESSAGE WHEN HE SMELLED A BURNING SMELL FROM THE CARD CAGE FOR ABOUT ONE MINUTE. NO AUDIBLE ALARMS WERE NOTED OR EXPECTED BECAUSE THE DIALYSATE LINES WERE ON THE SHUNT. THE MACHINE CONTINUED RUNNING AND HE COMPLETED A HEAT DISINFECT BEFORE TURNING IT OFF. THE NEXT MORNING THE STAFF TURNED THE MACHINE ON AND IT GAVE A FAILED SENDING DATA TO ACTUATOR BOARD MESSAGE. THE CARD CAGE WAS OPENED TO TROUBLESHOOT AND THE BIOMED TECH REPORTED SIGNS OF THE FIRE. THERE WAS DAMAGE TO THE BOARDS AND CABLES AND BLACK SOOT INDICATING THAT THERE HAD BEEN A FIRE. NO FLAMES OR SMOKE WERE NOTED, AND ONLY A SHORT BURNING SMELL WAS REPORTED. ADDITIONAL FOLLOW-UP WITH THE BIOMED TECH REVEALED DIODE 19 AND THE DRIVER IC BELOW IT WERE BURNT ON THE ACTUATOR BOARD. THE BIOMED TECH REPORTED HE HAD PERFORMED A PM ON THIS MACHINE AND REBUILT THE DEAERATION MOTOR, AND THE INCIDENT OCCURRED AFTER THE BIOMED TECH INSTALLED THE MOTOR AND RAN THE MACHINE. COMPONENTS WERE AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826146 T DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 00840861100897

    Patients

    Seq Age Sex Outcome Treatment
    1