BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAFLO II HEMOFILTER

    MDR report key: 8071247 · Received November 14, 2018

    Report

    Report Number
    2150060-2018-00070
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 14, 2018
    Manufacturer
    MEDIVATORS INC.
    Product Code
    KDI
    UDI-DI
    00677964000089
    PMA / PMN Number
    K923312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), DISTRIBUTOR OF HEMOFILTERS IN (B)(4), REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 180 ML 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 UNIT WAS NOT RETURNED FOR ANALYSIS BY MEDIVATORS QA. BASED ON PHOTOS PROVIDED, THE COMPLAINT OF A BLOOD FILTER LEAK WAS CONFIRMED. MEDIVATORS REMAINS IN CLOSE CONTACT WITH (B)(4). CONTINUED 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

    (B)(4), DISTRIBUTOR OF HEMOFILTERS IN (B)(4), REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 180 ML 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
    911257 RENAFLO II HEMOFILTER HIGH PERMEABILITY DIALYSIS SYSTEM KDI MEDIVATORS INC. HF 1200 906361 00677964000089

    Patients

    Seq Age Sex Outcome Treatment
    1 Other