BEUDAMED
    FDA Adverse Event Other Summary report: N

    GAMBRO

    MDR report key: 1061119 · Received June 13, 2008

    Report

    Report Number
    1713683-2008-00002
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    March 5, 2008
    Report Date
    April 17, 2008
    Manufacturer
    GAMBRO
    Product Code
    FII
    PMA / PMN Number
    K851306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE MACHINE WAS INSPECTED AND WAS FOUND TO BE OPERATING WITHIN MANUFACTURER'S SPECIFICATIONS. THIS MDR IS BEING FILED IN COMPLIANCE WITH GAMBRO POLICY, WHICH REQUIRES A FILING WHENEVER A PATIENT EXPIRES WITHIN 24 HOURS OF TREATMENT, REGARDLESS OF CAUSE. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OR RESPONSIBILITY FOR THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT EXPIRED DURING DIALYSIS TREATMENT ON A CENTRYSYSTEM 3 MACHINE. APPROXIMATELY TWO HOURS INTO TREATMENT, THE PATIENT STATED SHE WAS NOT FEELING WELL AND COLLAPSED. INITIALLY, CLINIC STAFF BEGAN CPR, HOWEVER IT WAS DISCONTINUED DUE TO THE PATIENT'S DO NOT RESUSCITATE ORDER. THE PATIENT EXPIRED. THERE WERE NO C3 MACHINE ALARMS THROUGH THE COURSE OF TREATMENT AND CLINIC STAFF STATED THAT TREATMENT HAD BEEN UNEVENTFUL. THE DEVICE WAS FUNCTIONALLY TESTED AND FOUND TO BE WORKING WITHIN MANUFACTURER'S SPECIFICATIONS. THERE IS NO INFORMATION THAT REASONABLY SUGGESTS ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other