BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 440470 · Received January 27, 2003

    Report

    Report Number
    2937457-2003-00003
    Event Type
    Malfunction
    Date Received
    January 27, 2003
    Date of Event
    December 30, 2002
    Report Date
    December 30, 2002
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A HOME PERITONEAL DIALYSIS PATIENT REPORTED THAT THE CYCLER DISPLAYED A "POWER OFF" MESSAGE WHILE PATIENT WAS GETTING READY TO START THEIR TREATMENT. PATIENT JIGGLED THE POWER CORD AND THE MESSAGE DISAPPEARED. PATIENT HEARD CRACKLING SOUND AND THEN SAW FLAMES ON THE BACK OF THE CYCLER. PATIENT UNPLUGGED THE CYCLER AND AFTER ABOUT A MINUTE, THE FLAMES DISAPEARED. PATIENT THEN SAW SMOKE COMING FROM THE BACK OF THE CYCLER. THE SMOKE ALSO DISAPPEARED AFTER ABOUT A MINUTE. THERE WAS NO INJURY/ILLNESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA