BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HD SYS. CDX W/BIBAG BLUE STAR

    MDR report key: 8621215 · Received May 17, 2019

    Report

    Report Number
    2937457-2019-01546
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 26, 2019
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861102099
    PMA / PMN Number
    K173972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE HEATER ROD WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERIOR INSPECTION REVEALED THE HEATER ROD SHOWS PARTIAL DISCOLORATION. THE BOTTOM SECTION IS NOT DISCOLORED LIKE THE TOP SECTION WAS FROM USAGE. THE HEATER ROD WAS CONNECTED TO TEST MACHINE AND RAN A 20 MINUTE HEAT DISINFECT, BUT THE TEMP EVENTUALLY STABILIZED AT 75 DEGREES ON SCREEN AND IR THERMOMETER READ 63.2 DEGREES. ON A REFERENCE MACHINE BOTH SCREEN AND IR READINGS WERE THE SAME 90 DEGREE TEMP. WHEN THE HEATER ROD WAS INSPECTED FOR OHMS, IT WAS READING 11.2 OHMS AS SPECIFIED IN HEATER BAR TEST INSTRUCTIONS. AN INTERNAL INSPECTION REVEALED NO DISCREPANCIES. 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.

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD VISIBLE HEAT DAMAGE AND DISCOLORATION TO THE HEATER. THE HEAT DAMAGE WAS NOTICED DURING MACHINE REPAIR FOR A TEMPERATURE FLUCTUATION ISSUE. 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. THE MACHINE HAS APPROXIMATELY 2 HOURS OF USE AND THE HEATER WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED AND MELTED DISTRIBUTION BOARD. A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) REPLACED THE HEATER TO RESOLVE THE ISSUE AND RETURN THE MACHINE TO SERVICE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE DAMAGED HEATER WAS REPORTEDLY RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414432 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 00840861102099

    Patients

    Seq Age Sex Outcome Treatment
    1