BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURALYTE 2301 2K 3.0CA 1MG GAL

    MDR report key: 10916188 · Received November 29, 2020

    Report

    Report Number
    3005162618-2020-00049
    Event Type
    Malfunction
    Date Received
    November 29, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 30, 2020
    Manufacturer
    OREGON MANUFACTURING PLANT
    Product Code
    KPO
    UDI-DI
    00840861101702
    PMA / PMN Number
    K192017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: A PRODUCT HISTORY REVIEW WAS PERFORMED. A REVIEW OF THE COMPLAINT MANAGEMENT SYSTEM IDENTIFIED 5 ADDITIONAL COMPLAINTS RELATED TO CONDUCTIVITY ISSUES WITH THE REPORTED LOT. A REVIEW OF THE PRODUCT INVENTORY RECORDS FOR LOT NO. INDICATED THAT (B)(6) OF FINISHED PRODUCT WERE MANUFACTURED FOR DISTRIBUTION WITH NO NOTED NONCONFORMANCES. AFTER REVIEWING THE FINISHED PRODUCT RELEASE SUMMARY, IT WAS DETERMINED THAT 20LXAC057 MET RELEASE SPECIFICATIONS. AS OF 12/17/2020 NO SAMPLES WERE RETURNED. SAMPLES ARE NOT NEEDED TO CONFIRM THE ALLEGATION. THROUGH OTHER COMPLAINT ALLEGATIONS OF THE SAME ISSUE FOR LOTS 20LXAC056, 20LXAC058, AND 20LXAC076, THERE WERE COMPANION SAMPLES AVAILABLE FOR TESTING WHICH WERE TESTED AT BOTH THE OREGON AND IRVING LABORATORIES AND RESULTS WERE FOUND TO BE CONFLICTING. DUE TO THE CONFLICTING RESULTS FOUND BETWEEN THE LABORATORIES, THE OREGON TEST METHODS WERE REVIEWED AND A DEFICIENCY WAS FOUND IN THE TEST METHOD PERTAINING TO THE SODIUM AND POTASSIUM ANALYTE TESTS. BECAUSE OF THE DEFICIENCY FOUND IN THE TEST METHOD, IT WAS DETERMINED THAT LOT 20LXAC057 DID NOT MEET RELEASE SPECIFICATIONS AND THE ALLEGATION CONDUCTIVITY LOW WAS CONFIRMED. IN CONCLUSION, 20LXAC057 RELEASE TESTING WAS FOUND TO BE COMPROMISED DUE TO THE DEFICIENT TEST METHOD. A NON-CONFORMANCE WAS OPENED FOR ALLEGATIONS OF CONDUCTIVITY ISSUES AND ESCALATED TO A CORRECTIVE ACTION PREVENTATIVE ACTION (CAPA). BASED ON THE INVESTIGATION PERFORMED, CAUSE WAS TRACED TO MANUFACTURING.

    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 FRESENIUS SALES MANAGER (FSM)REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A HEMODIALYSIS (HD) CLINIC REPORTED OUT OF RANGE CONDUCTIVITY LEVELS WITH NATURALYTE DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. UPON FOLLOW UP, THE FSM REPORTED DURING SETUP THE CONDUCTIVITY WAS AT 13.1 MS/CM AND THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.7 MS/CM. HE CONFIRMED NO PATIENTS WERE TREATED WITH THIS BATCH. THERE WAS NO RECENT SERVICE TO THE MACHINE. THERE WERE A TOTAL OF 47 CASES OF THIS REPORTED LOT. THE FSM WAS INFORMED A PICK UP WILL BE SCHEDULED FOR A SAMPLE RETURN. THEY ARE CURRENTLY USING NATURALYTE BICARBONATE, PRODUCT AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381304 NATURALYTE 2301 2K 3.0CA 1MG GAL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO OREGON MANUFACTURING PLANT NATURALYTE 2301 2K 3.0CA 1MG GAL 20LXAC057 00840861101702

    Patients

    Seq Age Sex Outcome Treatment
    1