BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAFLO II HEMOFILTER

    MDR report key: 8632573 · Received May 22, 2019

    Report

    Report Number
    2150060-2019-00045
    Event Type
    Death
    Date Received
    May 22, 2019
    Date of Event
    April 22, 2019
    Report Date
    July 12, 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 · 0

    BASED ON THE INITIALLY REPORTED INFORMATION AND ADDITIONAL DETAILS PROVIDED FOR THIS EVENT, IT HAS BEEN CONFIRMED THAT THE PATIENT WAS SEPTIC PRIOR TO THE HF 1200 HEMOFILTRATION PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED A FIBER LEAK OCCURRED, INDICATING THAT BLOOD WAS IDENTIFIED AS LEAKING FROM ONE OR MORE FIBERS AND WAS CAPTURED WITHIN THE FILTER CASING. A FIBER LEAK IS VISUALLY DETECTABLE BY THE OPERATOR. THE TIME AT WHICH THE LEAK OCCURRED DURING THE PROCEDURE WAS NOT DISCLOSED. THE PATIENT WAS REPORTED TO BE NEAR DEATH AND THE DECISION WAS MADE BY THE FACILITY AND PATIENT'S FAMILY TO SEND HIM HOME WHERE HE EXPIRED. IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED. GIVEN THE STATUS OF THE PATIENT BEING SEPTIC PRIOR TO THE HEMOFILTRATION PROCEDURE, AND THE RESULTS OF THE INVESTIGATION, IT IS BELIEVED THAT THE PATIENT OUTCOME IS UNLIKELY TO BE RELATED TO THE HF 1200 AND/OR REPORTED FIBER LEAK.

    Description of Event or Problem · 0

    BASED ON THE INITIALLY REPORTED INFORMATION AND ADDITIONAL DETAILS PROVIDED FOR THIS EVENT, IT HAS BEEN CONFIRMED THAT THE PATIENT WAS SEPTIC PRIOR TO THE HF 1200 HEMOFILTRATION PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED A FIBER LEAK OCCURRED, INDICATING THAT BLOOD WAS IDENTIFIED AS LEAKING FROM ONE OR MORE FIBERS AND WAS CAPTURED WITHIN THE FILTER CASING. A FIBER LEAK IS VISUALLY DETECTABLE BY THE OPERATOR. THE TIME AT WHICH THE LEAK OCCURRED DURING THE PROCEDURE WAS NOT DISCLOSED. THE PATIENT WAS REPORTED TO BE NEAR DEATH AND THE DECISION WAS MADE BY THE FACILITY AND PATIENT'S FAMILY TO SEND HIM HOME WHERE HE EXPIRED. IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED. GIVEN THE STATUS OF THE PATIENT BEING SEPTIC PRIOR TO THE HEMOFILTRATION PROCEDURE, AND THE RESULTS OF THE INVESTIGATION, IT IS BELIEVED THAT THE PATIENT OUTCOME IS UNLIKELY TO BE RELATED TO THE HF 1200 AND/OR REPORTED FIBER LEAK.

    Additional Manufacturer Narrative · 1

    (B)(4), DISTRIBUTOR OF MEDIVATORS HF 1200 HEMOFILTERS IN (B)(4), REPORTED A PATIENT EXPIRED WHILE THE HEMOFILTER WAS IN USE. DURING TREATMENT, IT WAS REPORTED A FIBER LEAK OCCURRED DURING HEMOFILTRATION OF THE PATIENT. THE TIME AT WHICH THE LEAK OCCURRED DURING THE PROCEDURE WAS NOT DISCLOSED. FURTHER ALONG IN THE PROCEDURE, THE PATIENT'S CONDITION DETERIORATED, THEY CODED, AND THEY WERE UNABLE TO BE RESUSCITATED. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF DEATH. MEDIVATORS ATTEMPTED TO FOLLOW UP WITH NO SUCCESS. PATIENT'S PRIOR HEALTH CONDITION IS UNKNOWN. THE UNIT WAS NOT RETURNED FOR ADDITIONAL INVESTIGATION BY MEDIVATORS QUALITY ASSURANCE. MEDIVATORS REMAINS IN CLOSE CONTACT WITH (B)(4). THIS IS A (B)(6) REGION-SPECIFIC EVENT. THERE HAVE BEEN NO RECENT COMPLAINTS OF HEMOFILTER LEAKS REPORTED FROM THE U.S. THERE ARE NO OTHER REPORTS OF PATIENT DEATH CONNECTED WITH MEDIVATORS HEMOFILTER PRODUCTS. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    (B)(4), DISTRIBUTOR OF MEDIVATORS HF 1200 HEMOFILTERS IN (B)(4), REPORTED A PATIENT EXPIRED WHILE THE HEMOFILTER WAS IN USE. DURING TREATMENT, IT WAS REPORTED A FIBER LEAK OCCURRED DURING HEMOFILTRATION OF THE PATIENT. THE TIME AT WHICH THE LEAK OCCURRED DURING THE PROCEDURE WAS NOT DISCLOSED. FURTHER ALONG IN THE PROCEDURE, THE PATIENT'S CONDITION DETERIORATED, THEY CODED, AND THEY WERE UNABLE TO BE RESUSCITATED. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425861 RENAFLO II HEMOFILTER HIGH PERMEABILITY DIALYSIS SYSTEM KDI MEDIVATORS INC. 934301A 00677964000089

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death