BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3840880 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17418
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, THE HOME PATIENT (HP) REPORTED DISCONNECTING THE HEATER BAG AND REPLACING IT WITH A SUPPLY BAG FROM A SEPARATE CASSETTE LINE. 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 FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING FOR A CHECK LINES AND BAGS ALARM, A TECHNICAL SERVICE REPRESENTATIVE (TSR) WAS INFORMED THAT A CARE GIVER (CG) DISCONNECTED THE HEATER BAG AND REPLACED IT WITH ONE OF THE USED SUPPLY BAGS. THE SWAP OCCURRED DURING THE FILL STAGE OF AUTOMATED PERITONEAL DIALYSIS (APD) USING A HOMECHOICE (HC) DEVICE. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE DISCONNECTION AND RECONNECTION OF THE BAGS. THE TSR REVIEWED PROPER PROCEDURES WITH THE CG AND INSTRUCTED THE CG TO CONTACT A REGISTERED NURSE (RN) REGARDING THE POTENTIAL CONTAMINATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318533 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE