BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3012361 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06659
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE LEAK WAS USE ERROR. AS THE CASSETTE WAS NOT RETURNED, A DEVICE ANALYSIS CANNOT BE COMPLETED. PER THE BAXTER HOMECHOICE OPERATOR'S MANUAL, USERS ARE WARNED NOT TO DISCONNECT WITHOUT USING PROPER PROCEDURES DURING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING AN ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 4 OF 4. THE HOME PATIENT (HP) HAD DISCONNECTED AND FLUID HAD LEAKED ON THE FLOOR. THE CALLER WOULD CALL THE REGISTERED NURSE (RN) REGARDING DISCONNECTING EARLY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115252 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOME CHOICE