BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 971212 · Received September 20, 2006

    Report

    Report Number
    9616240-2006-00442
    Event Type
    Death
    Date Received
    September 20, 2006
    Product Code
    FII
    PMA / PMN Number
    K010805
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED/REQUIRED. THIS PT HAD A DIAGNOSIS OF SEPTICEMIA AND MULTI-ORGAN FAILURE PRIOR TO STARTING ON PRISMA MACHINE. THE EVENTS HISTORY HAD BEEN ERASED AND THE TREATMENT SHEETS ARE NOT AVAILABLE. THE MACHINE WAS INSPECTED BY FACILITY'S BIOMEDICAL DEPT AND FOUND TO BE WORKING WITHIN MFR'S SPECIFICATIONS. THE MACHINE WAS THEN PLACED BACK INTO SERVICE WITHOUT COMPLICATIONS. THE FAMILY OF THE PT TERMINATED LIFE-SUSTAINING MEAURES ON THE PT FIVE DAYS AFTER THIS INCIDENT. IT IS NOT CLEAR, IF THE PT DIED WHEN CONNECTED TO THE MACHINE; HOWEVER, IT IS ASSUMED THAT SINCE LIFE-SUSTAINING MEASURES WERE TERMINATED THAT THE PT'S DEATH MOST LIKELY OCCURRED WITHIN HOURS. FACILITY'S NURSE EDUCATOR DENIED THAT THIS INCIDENT CONTRIBUTED TO THIS PT'S DEATH. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ITS DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FII

    Patients

    Seq Age Sex Outcome Treatment
    1