BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRYSYSTEM 3

    MDR report key: 752513 · Received August 11, 2006

    Report

    Report Number
    1713683-2006-00014
    Event Type
    Death
    Date Received
    August 11, 2006
    Date of Event
    June 22, 2005
    Report Date
    July 14, 2006
    Manufacturer
    GAMBRO HEALTH CARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 14, 2006, HEMACARE ADMINISTRATOR, REPORTED A CASE OF HEMOLYSIS OCCURRING IN 2005. THE PT WAS HOSPITALIZED AND REQUIRED THREE UNITS OF BLOOD. LAB VALUES INDICATE THAT THERE WAS HEMOLYSIS PRESENT. METHEMOGLOBIN RESULT OF 3.4% INDICATES A CHEMICAL HEMOLYSIS AND THERE IS NO EVIDENCE TO SUGGEST ACUTE MECHANICAL HEMOLYSIS. THERE IS INSUFFICIENT DATA TO CONCLUDE THAT ANY GAMBRO RENAL PRODUCTS (GRP) USED DURING THE TREATMENT CAUSED THIS HEMOLYSIS. REP REPORTED TO GRP THAT THE PT DIED IN 2006 OF CAUSES UNRELATED TO THE HEMOLYSIS INCIDENT.) ON-SITE FUNCTIONAL TESTING: GAMBRO WAS NOT NOTIFIED AT THE TIME OF THIS INCIDENT BECAUSE THE CLINICS DID NOT THINK IT WAS A MACHINE ISSUE. AS A CONSEQUENCE, NO MACHINE TESTING WAS PERFORMED IN THIS CASE. A PT INJURY DUE TO HEMOLYSIS OCCURRED IN THIS CASE. THE MFR IS UNABLE TO IDENTIFY THE ROOT CAUSE OF REPORTED HEMOLYSIS. AS A CONSEQUENCE, THE MFR CANNOT POSITIVELY EXCLUDE GAMBRO PRODUCT INVOLVEMENT; THEREFORE, AN MDR WILL BE SUBMITTED. NOTE THAT WITH CESSATION OF ALL MFG ACTIVITIES IN DEC 2000, GAMBRO RENAL PRODUCTS IS NO LONGER A MEDICAL DEVICE MFR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT DIALYZED ON: IN 2005. (THE FOLLOWING IS A SYNOPSIS OF CLINICAL INVESTIGATIONS REPORTED BY CLINICAL COMPLAINT INVESTIGATOR, DATED 2006. FULL REPORT DOCUMENTS ARE ATTACHED: ON JULY 14, 2006, HEMACARE ADMINISTRATOR, REPORTED A CASE OF HEMOLYSIS OCCURRING IN 2005. THE PT WAS HOSPITALIZED AND REQUIRED THREE UNITS OF BLOOD. LABORATORY VALUES INDICATE THAT THERE WAS HEMOLYSIS PRESENT. METHEMOGLOBIN RESULT OF 3.4% INDICATES A CHEMICAL HEMOLYSIS AND THERE IS NO EVIDENCE TO SUGGEST ACUTE MECHANICAL HEMOLYSIS. THERE IS INSUFFICIENT DATA TO CONCLUDE THAT ANY GAMBRO RENAL PRODUCTS (GRP) USED DURING THE TREATMENT CAUSED THIS HEMOLYSIS. REP REPORTED TO GRP THAT THE PT DIED IN 2006 OF CAUSES UNRELATED TO THE HEMOLYSIS INCIDENT. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED BY THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRYSYSTEM 3 HEMODIALYSIS MACHINE FII GAMBRO HEALTH CARE CENTRYSYSTEM 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death