BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2071992 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05141
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED BASED ON INFORMATION PROVIDED BY THE PATIENT AND THE ASSIGNABLE CAUSE WAS USE ERROR OF CLOSED CLAMP. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SLOW FLOW PATIENT ALARM. THE CARE GIVER (CG) ALSO STATED THAT THE HOME PATIENT (HP) HAD A LOT OF AIR BUBBLES IN THEIR PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO REPOSITION THE HP AND THEN TO DO A MANUAL DRAIN. THE CG STATED THAT ALL OF THE AIR BUBBLES WERE GONE NOW AND THE HOMECHOICE (HC) HADN'T ALARMED. THE CG STATED THAT THE HC HAD STOPPED THE MANUAL DRAIN. THE TSR THEN ASSISTED THE CG TO PRESS GO FOR THE FILL TO RESUME. 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
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE CYCLER