BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3120093 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12895
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR ANOTHER ISSUE, IT WAS FOUND THAT THE HOME PATIENT (HP) HAD MADE AN USE ERROR WHILE USING A HOMECHOICE (HC) MACHINE WITH A CASSETTE. THE HP HAD STEPPED ON THE PATIENT LINE, CAUSING THE PATIENT LINE TO DISCONNECT FROM THE TRANSFER SET. THE HP THEN RECONNECTED AND WANTED TO BYPASS TO FILL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THERAPY. THE TSR EXPLAINED THAT IF THE TRANSFER SET DISCONNECTS FROM THE PATIENT LINE SHE SHOULD NOT RECONNECT AND SHOULD END THERAPY AND START OVER WITH NEW SUPPLIES OR DO A MANUAL EXCHANGE INSTEAD. THE HP'S NURSE LATER STATED THAT THE EVENT WAS CAUSED BY USE ERROR AND NO ALLEGATIONS WERE MADE AGAINST ANY BAXTER PRODUCTS. THE HP WAS ADMINISTERED PROPHYLACTIC ANTIBIOTICS AND WAS CONTINUING THERAPY. THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT. THIS IS THE SAME PATIENT AS (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222300 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE| TRANSFER SET| UNKNOWN DIALYSIS SOLUTION