BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3021420 · Received March 26, 2013

    Report

    Report Number
    1416980-2013-07285
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 21, 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
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION; THEREFORE, NO FURTHER INVESTIGATION WILL BE PERFORMED. PER BAXTER LABELING, USERS ARE WARNED NOT TO RECONNECT DISCONNECTED SOLUTION BAGS 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

    A CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING SHE HAD CONNECTED THE FINAL BAG TO THE CASSETTE'S WHITE CLAMP LINE BUT THEN DISCONNECTED THE BAG AND RECONNECTED IT TO THE CASSETTE'S BLUE CLAMP LINE DURING PERITONEAL DIALYSIS WHILE THE HOME PATIENT (HP) WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE CG WAS RISKING AN INFECTION IN THE HP BY DISCONNECTING AND RECONNECTING. THE TSR ASSISTED THE CG WITH ENDING THERAPY AND ADVISED THE CG TO DISPOSE OF THE CURRENT SUPPLIES AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123842 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HOMECHOICE