BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH

    MDR report key: 8666060 · Received June 4, 2019

    Report

    Report Number
    2937457-2019-01767
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 26, 2019
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K153449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) PERFORMED AN ON-SITE EVALUATION. WHILE THE TECHNICIAN WAS ON SITE, THE USER SAID A 24V HIGH ISSUE APPEARS INTERMITTENTLY. THE TECHNICIAN FOUND NO FAILURES ON THE MACHINE BUT CLEANED THE BOARD (UNSPECIFIED) AND ASSURED THE REGULATOR (UNSPECIFIED) WAS WORKING 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-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. 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.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED TO FRESENIUS MEXICO THAT A 2008K2 MACHINE EXPERIENCED AN ULTRAFILTRATION (UF) VELOCITY FAILURE. THE EVENT OCCURRED WHILE A PATIENT WAS CONNECTED TO THE MACHINE. THE PATIENT COMPLETED TREATMENT ON THE SAME MACHINE. THERE WAS NO BLOOD LOSS. A FRESENIUS MEXICO TECHNICIAN WAS SCHEDULED TO SERVICE THE REPORTED MACHINE. UPON FOLLOW UP, THE TECHNICIAN REVIEWED THE MACHINE. USER REPORTED THAT THE 24 VOLTS FAILURE WAS APPEARING INTERMITTENTLY. THE TECHNICIAN FOUND NO FAILURES ON THE MACHINE BUT NONETHELESS CLEANED THE BOARD AND ASSURED THAT THE REGULATOR WAS WORKING PROPERLY. IT WAS NOTED THAT THE USER SUBSTITUTES THE HEAT DISINFECT WITH A HEATED WASH. TECHNICIAN ADVISED THE USER THAT THE DISINFECT SHOULD NOT BE REPLACED WITH ANOTHER METHOD. THE USER WAS ADVISED TO REFER TO TREATMENT GUIDE IN ORDER TO SEE THE FREQUENCY FOR HOW OFTEN THE MACHINE SHOULD BE WASHED AND DISINFECTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO FRESENIUS (B)(4) THAT A 2008K2 MACHINE EXPERIENCED AN ULTRAFILTRATION (UF) VELOCITY FAILURE. THE EVENT OCCURRED WHILE A PATIENT WAS CONNECTED TO THE MACHINE. THE PATIENT COMPLETED TREATMENT ON THE SAME MACHINE. THERE WAS NO BLOOD LOSS. A FRESENIUS (B)(4) TECHNICIAN WAS SCHEDULED TO SERVICE THE REPORTED MACHINE. DUE DILIGENCE ATTEMPTS WERE EXHAUSTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460310 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1