BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAFLO II HEMOFILTER

    MDR report key: 14415339 · Received May 17, 2022

    Report

    Report Number
    2150060-2022-00026
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Report Date
    May 16, 2022
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    KDI
    PMA / PMN Number
    K923312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED HEMOFILTER SUBJECT OF THE EVENT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE REPORTED PRODUCT IS INDICATED FOR SINGLE USE AND WAS EXCHANGED UPON DETECTION OF THE FILTER LEAK. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE REPORTED FILTER MET ALL PRE-RELEASE SPECIFICATIONS REGARDING STERILITY, BACTERIAL ENDOTOXIN TESTING, BIOCOMPATIBILITY, PRODUCT INTEGRITY AND DIMENSIONS. THE REPORTED EVENT DID NOT CAUSE OR CONTRIBUTE TO ANY SERIOUS INJURY OR DETERIORATION OF HEALTH AND IS NOT EXPECTED TO LEAD TO SERIOUS INJURY IF THE EVENT WERE TO RECUR. MEDIVATORS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED THAT DURING A PROCEDURE INVOLVING THE MEDIVATORS HF 1200 RENAFLO II HEMOFILTER, A FILTER LEAK OCCURRED RESULTING IN A PROCEDURE DELAY. THE REPORTED FILTER LEAK RESULTED IN AN APPROXIMATELY 100ML VOLUME OF PATIENT BLOOD LOSS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL REPORTS OF MALFUNCTION OR INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836387 RENAFLO II HEMOFILTER HIGH PERMEABILITY DIALYSIS SYSTEM KDI MEDIVATORS, INC. 528995

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown