BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3133746 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13601
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD THE DEVICE OR ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2367. THIS ERROR OCCURRED DURING THE INITIAL DRAIN CYCLE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT STATED THAT THE ISSUE HAD TO DO WITH THE HOMECHOICE MACHINE AND THAT HE DID NOT NOTICE ANYTHING WRONG WITH THE SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236628 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE