BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K HEMO. SYS. OLC/DIASAFE PLUS,W/O HP

    MDR report key: 7148016 · Received December 27, 2017

    Report

    Report Number
    2937457-2017-01426
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 21, 2017
    Report Date
    January 9, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861100859
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE DEVICE AND COMPONENT WERE 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.

    Additional Manufacturer Narrative · 1

    BRAND NAME: 2008K HEMO. SYS. OLC/DIASAFE PLUS,W/O HP. CATALOG: 190372. UNIQUE IDENTIFIER (UDI) REMOVED: (B)(4). A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A USER FACILITY BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED A DISCOLORED POWER CORD PLUG AND CONFIRMED THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY OCCURRED. THE BIOMED TECH STATED HE WAS REQUESTED TO PERFORM AN INSPECTION ON THE MACHINE AND NOTED THE POWER CORD APPEARED DISCOLORED AND BURNT AT THE PLUG. THE BIOMED TECH STATED THE DISCOVERED POWER CORD WAS REPLACED AND CONFIRMED NO SMOKE OR VISIBLE FLAMES WERE REPORTED FROM THE POWER PLUG. THE BIOMED TECH THE MACHINE FUNCTIONED AS INTENDED PRIOR TO THE OBSERVATION. NO DAMAGE TO THE MACHINE OR RECEPTACLE WAS NOTED, AND NO BURNING SMELL, SMOKE OR VISIBLE FLAME WAS REPORTED AS A RESULT OF THE REPORTED DAMAGED POWER CORD. THE BIOMED TECH STATED THE POWER PLUG WAS REPLACED AS A PRECAUTION AND THE MACHINE WAS PLACED BACK IN SERVICE WITHOUT ANY FURTHER ISSUE. THE POWER CORD WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A USER FACILITY BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED A DISCOLORED POWER CORD PLUG AND CONFIRMED THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY OCCURRED. THE BIOMED TECH STATED HE WAS REQUESTED TO PERFORM AN INSPECTION ON THE MACHINE AND NOTED THE POWER CORD APPEARED DISCOLORED AND BURNT AT THE PLUG. THE BIOMED TECH STATED THE DISCOVERED POWER CORD WAS REPLACED AND CONFIRMED NO SMOKE OR VISIBLE FLAMES WERE REPORTED FROM THE POWER PLUG. THE BIOMED TECH THE MACHINE FUNCTIONED AS INTENDED PRIOR TO THE OBSERVATION. NO DAMAGE TO THE MACHINE OR RECEPTACLE WAS NOTED, AND NO BURNING SMELL, SMOKE OR VISIBLE FLAME WAS REPORTED AS A RESULT OF THE REPORTED DAMAGED POWER CORD. THE BIOMED TECH STATED THE POWER PLUG WAS REPLACED AS A PRECAUTION AND THE MACHINE WAS PLACED BACK IN SERVICE WITHOUT ANY FURTHER ISSUE. THE POWER CORD WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A USER FACILITY BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED A DISCOLORED POWER CORD PLUG AND CONFIRMED THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY OCCURRED. THE BIOMED TECH STATED HE WAS REQUESTED TO PERFORM AN INSPECTION ON THE MACHINE AND NOTED THE POWER CORD APPEARED DISCOLORED AND BURNT AT THE PLUG. THE BIOMED TECH STATED THE DISCOVERED POWER CORD WAS REPLACED AND CONFIRMED NO SMOKE OR VISIBLE FLAMES WERE REPORTED FROM THE POWER PLUG. THE BIOMED TECH THE MACHINE FUNCTIONED AS INTENDED PRIOR TO THE OBSERVATION. NO DAMAGE TO THE MACHINE OR RECEPTACLE WAS NOTED, AND NO BURNING SMELL, SMOKE OR VISIBLE FLAME WAS REPORTED AS A RESULT OF THE REPORTED DAMAGED POWER CORD. THE BIOMED TECH STATED THE POWER PLUG WAS REPLACED AS A PRECAUTION AND THE MACHINE WAS PLACED BACK IN SERVICE WITHOUT ANY FURTHER ISSUE. THE POWER CORD WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927031 2008K HEMO. SYS. OLC/DIASAFE PLUS,W/O HP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 00840861100859

    Patients

    Seq Age Sex Outcome Treatment
    1