BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HEMODIALYSIS SYS., WITH CDX

    MDR report key: 6861795 · Received September 13, 2017

    Report

    Report Number
    2937457-2017-00878
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 25, 2017
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861100897
    PMA / PMN Number
    K093902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES). THE UNIT WAS PULLED FROM SERVICE FOR EVALUATION BY THE FACILITY BIOMEDICAL ENGINEER (BIOMED) FOLLOWING THE EVENT. THE BIOMED REPLACED THE NTC 2 AND NTC TO RESOLVE THE ISSUE. FOLLOWING PARTS REPLACEMENT, THE SYSTEM WAS CONFIRMED TO BE OPERATING PROPERLY. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCE'S OR ANY ASSOCIATED REWORK DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER (BIOMED) REPORTED A 2008T HEMODIALYSIS MACHINE THAT HAD NO TEMPERATURE IN SETUP OR HEAT DISINFECT. THE BIOMED TECH REPLACED THE NTC 2 AND NTC 3 SENSORS TO RESOLVE THE MACHINE ISSUE. THE NTC 2 SENSOR HAD A CRACK IN THE CASING AND THE SENSOR ON THE END OF NTC 3 HAD "BURNT OUT" AND LOOKED PHYSICALLY BURNT. THE MACHINE WAS REPAIRED AND BACK IN SERVICE AND THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED. NO PARTS WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINNER (BIOMED) REPORTED A 2008T HEMODIALYSIS MACHINE THAT HAD NO TEMPERATURE IN SETUP OR HEAT DISINFECT. THE BIOMED TECH REPLACED THE NTC 2 AND NTC 3 SENSORS TO RESOLVE THE MACHINE ISSUE. THE NTC 2 SENSOR HAD A CRACK IN THE CASING AND THE SENSOR ON THE END OF NTC 3 HAD "BURNT OUT" AND LOOKED PHYSICALLY BURNT. THE MACHINE WAS REPAIRED AND BACK IN SERVICE AND THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED. NO PARTS WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643143 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 00840861100897

    Patients

    Seq Age Sex Outcome Treatment
    1