BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 645325 · Received November 4, 2005

    Report

    Report Number
    2937457-2005-00017
    Event Type
    Injury
    Date Received
    November 4, 2005
    Date of Event
    October 5, 2005
    Report Date
    October 5, 2005
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED BY THE NEWS MEDIA STATED THAT A FIRE OCCURRED IN A HOME RESULTING IN THE DEATH OF SOME FAMILY MEMBERS. IT WAS REPORTED THAT THE DISEASED FAMILY MEMBER WAS ASLEEP AND USING A DIALYSIS MACHINE (CYCLER) IN THE LIVING ROOM. THE FIRE BROKE OUT AROUND 2:00 A.M. THE FAMILY MEMBER ESCAPED THE FIRE AND WAS HOSPITALIZED FOR INJURIES SUSTAINED WHILE ATTEMPTING TO GET THE VICTIMS OUT. IT WAS REPORTED THAT THE CYCLER WAS CONNECTED TO AN ELECTRICAL EXTENSION CORD. THE EXACT CAUSE OF THE FIRE IS UNKNOWN AND IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 2

    INFORMATION PROVIDED BY THE NEWS MEDIA STATED THAT A FIRE OCCURRED IN A HOME RESULTING IN THE DEATH OF SOME FAMILY MEMBERS. IT WAS REPORTED THAT THE DISEASED FAMILY MEMBER WAS ASLEEP AND USING A DIALYSIS MACHINE (CYCLER) IN THE LIVING ROOM. THE FIRE BROKE OUT AROUND 2:00 A.M. THE FAMILY MEMBER ESCAPED THE FIRE AND WAS HOSPITALIZED FOR INJURIES SUSTAINED WHILE ATTEMPTING TO GET THE VICTIMS OUT. IT WAS REPORTED THAT THE CYCLER WAS CONNECTED TO AN ELECTRICAL EXTENSION CORD. THE EXACT CAUSE OF THE FIRE IS UNKNOWN AND IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 3

    INFORMATION PROVIDED BY THE NEWS MEDIA STATED THAT A FIRE OCCURRED IN A HOME RESULTING IN THE DEATH OF SOME FAMILY MEMBERS. IT WAS REPORTED THAT THE DISEASED FAMILY MEMBER WAS ASLEEP AND USING A DIALYSIS MACHINE (CYCLER) IN THE LIVING ROOM. THE FIRE BROKE OUT AROUND 2:00 A.M. THE FAMILY MEMBER ESCAPED THE FIRE AND WAS HOSPITALIZED FOR INJURIES SUSTAINED WHILE ATTEMPTING TO GET THE VICTIMS OUT. IT WAS REPORTED THAT THE CYCLER WAS CONNECTED TO AN ELECTRICAL EXTENSION CORD. THE EXACT CAUSE OF THE FIRE IS UNKNOWN AND IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 4

    INFORMATION PROVIDED BY THE NEWS MEDIA STATED THAT A FIRE OCCURRED IN A HOME RESULTING IN THE DEATH OF SOME FAMILY MEMBERS. IT WAS REPORTED THAT THE DISEASED FAMILY MEMBER WAS ASLEEP AND USING A DIALYSIS MACHINE (CYCLER) IN THE LIVING ROOM. THE FIRE BROKE OUT AROUND 2:00 A.M. THE FAMILY MEMBER ESCAPED THE FIRE AND WAS HOSPITALIZED FOR INJURIES SUSTAINED WHILE ATTEMPTING TO GET THE VICTIMS OUT. IT WAS REPORTED THAT THE CYCLER WAS CONNECTED TO AN ELECTRICAL EXTENSION CORD. THE EXACT CAUSE OF THE FIRE IS UNKNOWN AND IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM CYCLER PD+ PERITONEAL DIALYSIS CYCLER KPF FRESENIUS MEDICAL CARE NORTH AMERICA NEWTON IQ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization
    2 36 YR Death
    3 9 YR Death
    4 11 YR Death