BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3243545 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19498
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 29, 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 CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE PATIENT DISCONNECTED WITHOUT USING PROPER PROCEDURES, THEN RECONNECTED. USE ERROR AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ?THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE? WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER NOT TO REPLACE EMPTY SOLUTION BAGS OR RECONNECT DISCONNECTED SOLUTION BAGS DURING THERAPY. IT ALSO WARNS THE USER THAT POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) DISCONNECTED AND RECONNECTED THE HEATER BAG DURING ACTIVE PRIME ON A HOMECHOICE (HC) DEVICE DURING USE FOR PERITONEAL DIALYSIS (PD) THERAPY. THE TSR REVIEWED PROPER SETUP PROCEDURE WITH THE HP AND INSTRUCTED HER TO SETUP WITH ALL NEW SUPPLIES. THE HP WOULD FINISH THERAPY WITH MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342607 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