BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2993189 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05517
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 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). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR (SE) 2240 WAS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED THAT CLAMPS ON ANY UNUSED SOLUTION LINES MUST REMAIN CLOSED WHEN PERFORMING 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) DURING DWELL 3 OF 5 ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) CHECKED THE LINES AND BAGS AND FOUND THAT THE UNUSED FINAL LINE CLAMP WAS OPEN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE PROPER SETUP PROCEDURES. THE HP WOULD NOTIFY THE PERITONEAL DIALYSIS NURSE (PDN) OF MISSED THERAPY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98207 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR HOMECHOICE