BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAFLO II HEMOFILTER

    MDR report key: 8604439 · Received May 13, 2019

    Report

    Report Number
    2150060-2019-00041
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 13, 2019
    Manufacturer
    MEDIVATORS INC.
    Product Code
    KDI
    UDI-DI
    00677964000089
    PMA / PMN Number
    K923312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NIKKISO, DISTRIBUTOR OF HEMOFILTERS IN (B)(4), REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 200ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT. THE COMPLAINT REPORTED A FILTER LEAK FROM THE HEADER OF THE UNIT CAUSING THE BLOOD LOSS. NIKKISO REPORTED PRODUCT WILL BE RETURNED FOR MEDIVATORS QUALITY INVESTIGATION. HOWEVER, PRODUCT HAS NOT BEEN RETURNED YET. THEREFORE, MEDIVATORS CANNOT CONFIRM THE COMPLAINT OF A HEADER LEAK AT THIS TIME. MEDIVATORS REMAINS IN CLOSE CONTACT WITH NIKKISO. CONTINUES INVESTIGATION IS UNDERWAY. THIS IS A CHINA REGION-SPECIFIC EVENT. THERE HAVE BEEN NO RECENT COMPLAINTS OF HEMOFILTER LEAKS REPORTED FROM THE U.S. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    NIKKISO, DISTRIBUTOR OF HEMOFILTERS IN (B)(4), REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 200ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398683 RENAFLO II HEMOFILTER HIGH PERMEABILITY DIALYSIS SYSTEM KDI MEDIVATORS INC. 924133A 00677964000089

    Patients

    Seq Age Sex Outcome Treatment
    1 Other