BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2904822 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00689
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT FOR A REPORT OF A USE ERROR - REUSE OF A SINGLE-USE PRODUCT WAS CONFIRMED; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK BAGS AND LINES ALARM, WHICH APPEARED ON THE HOMECHOICE (HC) DURING FILL 4 OF 4, THE HOME PATIENT (HP) STATED THEY DISCONNECTED BAG AND THEN CONNECTED A NEW SOLUTION BAG. THE FILL VOLUME (FV) WAS EQUAL TO 1299ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SETUP WAS THEN COMPROMISED. THE TSR ASSISTED IN ENDING THERAPY. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12753 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR BAG