BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIPOSORBER LA-15 SYSTEM

    MDR report key: 6183191 · Received December 16, 2016

    Report

    Report Number
    9614654-2016-00022
    Event Type
    Death
    Date Received
    December 16, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    KANEKA CORP.
    Product Code
    MMY
    UDI-DI
    14993478010110
    PMA / PMN Number
    P910018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR IN CHARGE SAID THAT THE CAUSE OF HER DEATH WAS MYOCARDIAL INFARCTION AND WAS NOT ATTRIBUTABLE TO THE LDL-A . AS THE PHYSICIAN STATED SHE DIED OF MYOCARDIAL INFARCTION. HOWEVER, HER LATER DEVELOPMENT OF MYOCARDIAL INFARCTION MIGHT HAVE BEEN RELEVANT TO A SUDDEN CHANGE IN HER PHYSICAL CONDITION DURING THE LDL-A SUCH AS DYSPNEA. FUTHAN SHOCK, BRADYKININ RELATED ANAPHYLACTOID REACTION, ETC. MIGHT BE POSSIBLE CAUSES OF THE SUDDEN CHANGE IN HER PHYSICAL CONDITION DURING THE LDL-A. THE ANTIBODY TEST TO FUTHAN ON THE DAY BEFORE THE EVENT WAS NEGATIVE, WHEREAS THE RESULT OF THE ALLERGIC TEST TO FUTHAN OF THE PATIENT WAS NOT AVAILABLE. THE BRADYKININ RELATED ANAPHYLACTOID REACTION CAN BE DENIED BECAUSE OF THE USE OF FUTHAN AS AN ANTICOAGULANT DURING THE LDL-A ON THE EVENT. FUTHAN IS KNOWN TO SUPPRESS BRADYKININ GENERATION DURING THE LDL-A. ALTHOUGH THE PHYSICIAN IN CHARGE COMMENTED THAT THE LDL-A WAS NOT RELEVANT TO THE PATIENT'S DEATH, A POSSIBILITY THAT THE LDL-A WAS RELEVANT TO THE CATASTROPHIC EVENTS OCCURRED DURING THE LDL-A CANNOT, WE CONSIDER, BE COMPLETELY EXCLUDED.

    Description of Event or Problem · 1

    THE SUBJECT IS A HEMODIALYSIS PATIENT COMPLICATED WITH ARTERIOSCLEROSIS OBLITERANS (ASO) . SHE HAS A HISTORY OF DIABETES AND WAS PUT ON A PACEMAKER. SHE WAS TREATED BY LDL-APHERESIS (LDL-A) USING LIPOSORBER LA-15 SYSTEM FOR THE TREATMENT OF ASO. IT WAS HER 6TH LDL-A TREATMENT OF THE 3RD COURSE OF LDL-A WHEN THE EVENT OCCURRED. USUALLY ONE COURSE OF LDL-A ON ASO CONSISTS OF 10 TREATMENTS. HER PHYSICAL CONDITION CHANGED SUDDENLY AND SHE CAUSED DYSPNEA AT ABOUT 50MIN AFTER STARTING LDL-A. THE EXTRACORPOREAL BLOOD WAS RETURNED TO HER IMMEDIATELY. SINCE EVEN AFTER BRONCHIAL INTUBATION AND OXYGEN INHALATION SHE DID NOT RECOVER, SHE WAS TRANSFERRED TO THE GENERAL HOSPITAL WHICH THIS DIALYSIS CENTER WAS AN AFFILIATE OF. THE VALUES OF OXYGEN SATURATION WERE 98% AT THE START OF LDL-A AND 70% AT THE ONSET OF EVENT. HER SYSTOLIC BLOOD PRESSURE WAS 90MMHG USUALLY BEFORE LDL-A AND WAS 120MMHG AT THE ONSET OF THE EVENT. FUTHAN (OR NAFAMOSTAT MESILATE), A PROTEASE INHIBITOR, WAS USED AS THE ANTICOAGULANT OF LDL-A SINCE THE 3RD LDL-A CONVERTING FROM HEPARIN, BECAUSE SHE DEVELOPED A FEELING OF BREATHING DIFFICULTY DURING LDL-A UNDER HEPARIN, WHICH MIGHT HAVE CAUSED BY INCREASE IN BRADYKININ GENERATION. THE RESULT OF THE ANTIBODY TEST ON FUTHAN WAS NEGATIVE ON THE DAY BEFORE THE EVENT. LDL-A CONDITIONS ON THE DAY OF THE EVENT: THE BLOOD FLOW RATE (QB) WAS 100ML/.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833294 LIPOSORBER LA-15 SYSTEM LIPOPROTEIN, LOW DENSITY, REMOVAL MMY KANEKA CORP. LA-15 14993478010110

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR