BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRISOL HEMODIALYSIS ACID CONCENTRATE

    MDR report key: 11718016 · Received April 23, 2021

    Report

    Report Number
    2150060-2021-00006
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    April 9, 2021
    Report Date
    April 23, 2021
    Manufacturer
    MEDIVATORS
    Product Code
    FKQ
    UDI-DI
    00677964000577
    PMA / PMN Number
    K843963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED POSITIVE DETECTION OF OXIDIZING AGENTS IN THEIR DIALYSATE USING CENTRISOL ACID CONCENTRATE LOT 489224.FURTHER CUSTOMER TESTING CONFIRMED THE PRESENCE OF OXIDIZING AGENTS IN THE CENTRISOL ACID CONCENTRATE. INVESTIGATIONS PERFORMED BY MEDIVATORS ON RETURNED PRODUCTS CONFIRMED THAT A LIMITED SUBSET OF BOTTLES FROM THE IMPACTED LOT CONTAIN AN OUT-OF-SPECIFICATION CONCENTRATION FORMULATION DUE TO THE PRESENCE OF AN OXIDIZING AGENT.. A RECALL OF ALL PRODUCTS FROM THE IMPACTED LOT WILL BE CONDUCTED AND THE SITUATION WILL BE COMMUNICATED TO IMPACTED CUSTOMERS. THE USE OF OUT-OF-SPECIFICATION FORMULATIONS OF THE CONCENTRATE MAY PRESENT A RISK WHEN USED IN PATIENT PROCEDURES. HOWEVER, BOTH TEST STRIP USAGE AND CONDUCTIVITY CHECKS ARE INDICATED AS STANDARD CLINICAL PRACTICE AND WOULD MAKE THE SITUATION DETECTABLE TO THE USER. NO HARM HAS BEEN REPORTED AS A RESULT OF THIS SITUATION. MEDIVATORS HAS OPENED CAPA-(B)(4). TO ADDRESS THIS SITUATION. MEDIVATORS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT PERFORMS AS EXPECTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED POSITIVE DETECTION OF OXIDIZING AGENTS IN THEIR DIALYSATE USING CENTRISOL ACID CONCENTRATE LOT 489224. FURTHER CUSTOMER TESTING CONFIRMED THE PRESENCE OF OXIDIZING AGENTS IN THE CENTRISOL ACID CONCENTRATE. NO HARM HAS BEEN REPORTED AS A RESULT OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617486 CENTRISOL HEMODIALYSIS ACID CONCENTRATE CENTRISOL HEMODIALYSIS CONCENTRATE FKQ MEDIVATORS SB-143 489224 00677964000577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other