BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008K HEMODIALYSIS SYSTEM

    MDR report key: 4200879 · Received October 22, 2014

    Report

    Report Number
    2937457-2014-03025
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REQUESTING PATIENT MEDICAL RECORDS AND TREATMENT DATA INFO REGARDING THE REPORTED EXPIRATION DURING THE HOSPITALIZATION. NO ALLEGATION OF DEVICE MALFUNCTION HAS BEEN MADE. THIS FILE IS BEING REPORTED FOR THE PATIENT DEATH. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING A FOLLOW UP OF AN UNRELATED COMPLAINT, THE CLINICAL MANAGER OF A CHRONIC OUTPATIENT DIALYSIS UNIT REPORTED THE PATIENT HAD EXPIRED ON (B)(6) 2014 WHILE HOSPITALIZED FOR AN UNK REASON. SUBSEQUENT FOLLOW UP WITH THE CLINICAL MANAGER FOR THIS EVENT WAS PERFORMED. ACCORDING TO THIS CLINICAL MANAGER, THIS PATIENT HAD A LONG HISTORY OF MULTIPLE CO-MORBIDITIES BEGINNING IN HER TEENS. THESE INCLUDE CHRONIC LIVER AND KIDNEY PROBLEMS. THE PATIENT WAS ORIGINALLY ON PERITONEAL DIALYSIS BUT CHANGED TO HEMODIALYSIS IN (B)(6) 2014 BECAUSE OF MULTIPLE PERITONITIS EVENTS REPORTEDLY FROM BREACHES IN ASEPTIC TECHNIQUE. SHE WAS HEMODIALYZING VIA A PERMCATH IN HER CHEST DUE TO MULTIPLE FAILED ARTERIOVENOUS FISTULA/GRAFT ATTEMPTS. FURTHER , THE CLINICAL MANAGER REPORTS THE PATIENT WAS HOSPITALIZED FOR THE FINAL TIME ON (B)(6) 2014 FOR AN UNK REASON. TO THE BEST OF HER KNOWLEDGE, THE PATIENT WAS RECEIVING HEMODIALYSIS DURING THE HOSPITALIZATION BUT THE DETAILS OF THE HOSPITALIZATION ARE UNK TO HER. SHE ASSERTS THERE IS NO ALLEGATION OF DEVICE MALFUNCTION NOR WAS IT MADE KNOWN TO HER THAT THE PATIENT WAS IN TREATMENT AT THE TIME OF HER DEATH. SHE STATES THE PATIENT SUFFERED MULTI-ORGAN SYSTEM FAILURE DURING THIS HOSPITALIZATION AND ULTIMATELY PASSED AWAY, CAUSE OF DEATH: SEPTICEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674085 2008K HEMODIALYSIS SYSTEM KDI KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death