BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRYSYSTEM 3

    MDR report key: 748640 · Received August 11, 2006

    Report

    Report Number
    1713683-2006-00016
    Event Type
    Death
    Date Received
    August 11, 2006
    Date of Event
    July 8, 2006
    Report Date
    July 12, 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

    THIS ISSUE IS LISTED IN CS3 COE MDR, MDV AND MVPR REPORTING SOP COE 202 TABLE OF NON-MDR-REPORTABLE EVENTS: POOR OCCLUSION OF THE BLOOD PUMP RACEWAY BY THE BLOOD PUMP ROTOR. THE ASSOCIATED RATIONALE STATES: I AS OCCLUSION DECREASES, PRESSURES AND FLOWS WITHIN THE BLOOD SET BECOME MORE ERRATIC AND ATYPICAL OF NORMAL CLINICAL EXPERIENCE (E.G.. A BROKEN ROTOR SPRING). THIS WILL ALERT THE USER TO THE MORE SEVERE CASES OF UNDER-OCCLUSION. IN ALL CASES, INCLUDING THE LESS SEVERE ONES, THE REDUCED BLOOD FLOW WILL CAUSE REDUCED PATIENT CLEARANCES OF SPECIFIC UREMIC TOXINS. SINCE FACILITIES ROUTINELY TRACK BLOOD LEVELS OF KEY METABOLIC PARAMETERS INCLUDING BUN, CREATININE, ETC., REDUCTIONS IN CLEARANCE WILL BE VISIBLE TO THE FACILITY, ALERTING THEM TO A POTENTIAL PROBLEM. THIS TYPE OF URENIA DOES NOT PRESENT A LIKELIHOOD OF PERMANENT INJURY. SUPPORTING THIS IS THE FACT THAT UNDER-OCCLUSTION (EXCEPT FOR BROKEN SPRINGS) WILL OCCUR GRADUALLY WITH WEAR, SO THAT CHANGES IN PATIENT BLOOD ARE GRADUAL AND WILL BE DETECTED AND ADDRESSED BY THE PATIENT'S MONTHLY BLOOD CHEMISTRY EVALUATION. UNDER-OCCLUSION PUTS LESS THAN NORMAL STRESSES ON THE BLOOD DURING BLOOD DELIVERY; THEREFORE, IT DOES NOT CONTRIBUTE TO POTENTIAL HEMOLYSIS. DUE TO OTHER REPORTS OF HEMOLYSIS INCIDENTS AT THIS AND AN ASSOCIATED CLINIC, AN MDR WILL BE SUBMITTED. NOTE THAT WITH CESSATION OF ALL MANUFACTURING ACTIVITIES IN DECEMBER 2000, GAMBRO RENAL PRODUCTS IS NO LONGER A MEDICAL DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DIALYZED ON: 07/08/2006. (THE FOLLOWING IS A SYNOPSIS OF CLINICAL INVESTIGATIONS REPORTED BY CLINICAL COMPLAINT INVESTIGATOR, DATED JULY 20, 2006. FULL REPORT DOCUMENTS ARE ATTACHED: THE FACILITY REPORTED AN INCIDENT OF HEMOLYSIS IN 2006. HOWEVER, UPON REVIEW OF THE PATIENT'S CASE, THE NEPHROLOGIST RULED OUT HEMOLYSIS AS THE CAUSE OF DEATH. THE RN, NURSE MANAGER, STATED THAT THE REPORTED CAUSE OF DEATH WAS GASTROINTESTINAL BLEEDING. THERE IS NO EVIDENCE THAT SUGGESTS THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THIS INCIDENT.) THE PATIENT'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 62 YR Death| R