BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 2555996 · Received April 26, 2012

    Report

    Report Number
    2937457-2012-00017
    Event Type
    Death
    Date Received
    April 26, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 14, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FII
    PMA / PMN Number
    K994267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFO. MFR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO FRESENIUS MEDICAL CARE THAT A PT EXPIRED ABOUT ONE HOUR INTO A HEMODIALYSIS TREATMENT, INVESTIGATION IS ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE FII FRESENIUS MEDICAL CARE NORTH AMERICA 2008K NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death