BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITRASATE ACID CONC. K3, CA2.5 4/CS

    MDR report key: 11617045 · Received April 5, 2021

    Report

    Report Number
    3005162618-2021-00019
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    October 27, 2020
    Report Date
    April 15, 2021
    Manufacturer
    OREGON MANUFACTURING PLANT
    Product Code
    KPO
    UDI-DI
    00840861101351
    PMA / PMN Number
    K192017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H3 PLANT INVESTIGATION: A PRODUCT HISTORY REVIEW WAS PERFORMED. A REVIEW OF THE COMPLAINT MANAGEMENT SYSTEM IDENTIFIED 16 ADDITIONAL COMPLAINTS RELATED TO CONDUCTIVITY ISSUES WITH THE REPORTED LOT. A REVIEW OF THE PRODUCT INVENTORY RECORDS FOR LOT NO. 20LXAC051 INDICATED THAT (B)(4) CASES OF FINISHED PRODUCT WERE MANUFACTURED FOR DISTRIBUTION WITH NO NOTED NONCONFORMANCES. AFTER REVIEWING THE FINISHED PRODUCT RELEASE SUMMARY, IT WAS DETERMINED THAT 20LXAC051 MET RELEASE SPECIFICATIONS. AS OF 04/01/2021 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 20LXAC051 DID NOT MEET RELEASE SPECIFICATIONS AND THE ALLEGATION CONDUCTIVITY LOW WAS CONFIRMED. IN CONCLUSION, 20LXAC051 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.

    Description of Event or Problem · 0

    A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A BATCH OF CITRASATE ACID CONCENTRATE WAS NOT ACHIEVING THE DESIRED CONDUCTIVITY. UPON FOLLOW UP, THE BMT INDICATED THEY WERE NOT SURE IF THE LOW CONDUCTIVITY WAS OBSERVED DURING SETUP OR TREATMENT. HE CONFIRMED THE UNSPECIFIED HEMODIALYSIS (HD) MACHINE ALARMED APPROPRIATELY. THE BMT DOES NOT RECALL THE EXACT CONDUCTIVITY LEVELS THAT WERE OBSERVED. IT WAS INDICATED THERE WAS NO ADVERSE EVENT, SERIOUS INJURY, NOR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE REMAINING JUGS OF THE REPORTED LOT WERE SEQUESTERED AND FRESENIUS CUSTOMER SERVICE SCHEDULED TO RETURN THE REPORTED PRODUCT.

    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 USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A BATCH OF CITRASATE ACID CONCENTRATE WAS NOT ACHIEVING THE DESIRED CONDUCTIVITY. UPON FOLLOW UP, THE BMT INDICATED THEY WERE NOT SURE IF THE LOW CONDUCTIVITY WAS OBSERVED DURING SETUP OR TREATMENT. HE CONFIRMED THE UNSPECIFIED HEMODIALYSIS (HD) MACHINE ALARMED APPROPRIATELY. THE BMT DOES NOT RECALL THE EXACT CONDUCTIVITY LEVELS THAT WERE OBSERVED. IT WAS INDICATED THERE WAS NO ADVERSE EVENT, SERIOUS INJURY, NOR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE REMAINING JUGS OF THE REPORTED LOT WERE SEQUESTERED AND FRESENIUS CUSTOMER SERVICE SCHEDULED TO RETURN THE REPORTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513967 CITRASATE ACID CONC. K3, CA2.5 4/CS DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO OREGON MANUFACTURING PLANT 08-3251-CA 20LXAC051 00840861101351

    Patients

    Seq Age Sex Outcome Treatment
    1