BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTRYSYSTEM 3

    MDR report key: 1061126 · Received June 13, 2008

    Report

    Report Number
    1713683-2008-00003
    Event Type
    Other
    Date Received
    June 13, 2008
    Manufacturer
    GAMBRO
    Product Code
    FII
    PMA / PMN Number
    K851306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MACHINE WAS INSPECTED AND WAS FOUND TO BE OPERATING WITHIN MANUFACTURER'S SPECIFICATIONS. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THIS EVENT IS BEING REPORTED AS PER GAMBRO POLICY: ALL CASES OF PATIENT'S DEATH WITHIN 24 HOURS OF TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF LIABILITY.

    Description of Event or Problem · 1

    GAMBRO BECAME AWARE OF AN ARTICLE IN THE STATE JOURNAL-REGISTER NEWSPAPER, (B) (6), ON (B) (6) 2008, THAT A (B) (6) MALE EXSANGUINATED AND EXPIRED DUE TO LOOSE TUBING ON A DIALYSIS MACHINE. ACCORDING TO THE CLINICS TECHNICAL MANAGER, ON (B) (6) 2008, ABOUT FORTY FIVE MINUTES AFTER STARTING TREATMENT ON A 68 YEAR-OLD MALE, THE MACHINE GENERATED AN UNKNOWN ALARM THAT BROUGHT THE CLINIC STAFF TO THE PATIENT'S TREATMENT AREA. CLINIC STAFF DISCOVERED THAT THE VENOUS BLOOD LINE WAS DISCONNECTED FROM THE PATIENT'S CATHETER. A POOL OF BLOOD WAS OBSERVED ON THE FLOOR, STAFF BEGAN RESUSCITATION EFFORTS AND SUBSEQUENTLY THE PATIENT WAS TRANSPORTED TO A LOCAL HOSPITAL, WHERE HE WAS PRONOUNCED DEAD. THE MACHINE WAS INSPECTED BY THE CLINIC'S BIOMEDICAL TECHNICIANS. THEY DETERMINED THAT THE MACHINE WAS FUNCTIONING WITHIN ALL MANUFACTURERS' SPECIFICATIONS. THEY CHECKED THE ARTERIAL AND VENOUS PRESSURE CALIBRATIONS AND ALARM FUNCTIONALITY, THE VENOUS LINE CLAMP FUNCTIONALITY, THE ABD SENSITIVITY AND FUNCTIONALITY, THEY PERFORMED AN AUTO TEST PROCEDURE WHICH THE MACHINE PASSED, AND THEN PERFORMED A SIMULATED TREATMENT. NO PROBLEMS WERE NOTED. THE DIALYSATE WAS CHECKED FOR ELECTROLYTE CONCENTRATION AND FOR BACTERIOLOGY AND ALL VALUES WERE WITHIN LIMITS. AS OF (B) (6) 2008 THE MACHINE HAS NOT BEEN RETURNED TO SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other