BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3961186 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24439
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, NO EVALUATION COULD BE PERFORMED. IT WAS REPORTED THAT THE PATIENT REUSED SINGLE USE SUPPLIES. 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 INSTRUCTS THE USER NOT TO ATTEMPT TO REUSE ANY DISPOSABLE SUPPLIES AND 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 THE HOME PATIENT (HP) HAD REUSED SINGLE-USE SUPPLIES WHILE THEY WERE PERFORMING PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE DEVICE. THE HP STATED THAT THEY HAD ISSUES WITH UNRELATED ALARMS AND IN AN ATTEMPT TO TROUBLESHOOT, THEY SWITCHED OUT THE SUPPLY BAGS (BUT NOT THE REST OF THE SUPPLIES). THE HP RECONNECTED FOR THERAPY AFTER SWITCHING OUT THE BAGS. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE HP AGAINST DOING THAT IN THE FUTURE. 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
    439170 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE