BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3133564 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13577
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AIR IN THE PATIENT LINE OF AN AUTOMATED PD SET WITH CASSETTE. THIS OCCURRED DURING THE INITIAL DRAIN CYCLE OF THE HOMECHOICE DEVICE. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ADVISED THE PATIENT TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE PATIENT STATED THAT THE HOMECHOICE DID NOT ALARM FOR AIR AND SHE DID NOT SEE ANY OBVIOUS REASONS FOR THE AIR. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234952 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE