BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3834212 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17144
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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

    IT WAS REPORTED THAT A HOMECHOICE AUTOMATED PD SET WITH CASSETTE HAD AIR IN THE PATIENT LINE. THIS WAS IDENTIFIED DURING FILL CYCLE TWO OF FOUR OF PERITONEAL DIALYSIS THERAPY WHILE THE PATIENT WAS CONNECTED. THE PATIENT STATED THAT THE HOMECHOICE HAD "PUSHED AIR¿ INTO THEM. THE PATIENT FURTHER STATED THAT THEY HAD IMPROPERLY CONNECTED THE BAGS. THE PATIENT STATED THEY HAD CONNECTED THE HEATER LINE TO THE SUPPLY BAG AND THE SUPPLY LINE TO THE HEATER BAG. THE PATIENT HAD THEN DISCONNECTED BOTH BAGS AND RECONNECTED THEM TO THE CORRECT LINES. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE PATIENT TO CHECK THE PATIENT LINE FOR AIR BEFORE CONNECTING AND ADVISED THE PATIENT TO END THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310043 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR HOMECHOICE