BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2010994 · Received March 8, 2011

    Report

    Report Number
    1423500-2011-02853
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 13, 2011
    Report Date
    February 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CURRENT LABELING FOR THE HOMECHOICE/HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE WAS FOUND TO BE SUFFICIENT. BASED ON THE AVAILABLE INFORMATION; THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE USE ERROR (OPENING THE DOOR PRIOR TO THERAPY ENDING. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A SERVICE HISTORY REVIEW, DEVICE HISTORY REVIEW AND DEVICE EVALUATION WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A CHECK PATIENT LINE ALARM, THE HOME PATIENT (HP) STATED THEY HAD GOTTEN THE DOOR OPEN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP THAT THEY WERE NOT TO OPEN ANY DOOR AND WOULD NEED TO START OVER WITH NEW SUPPLIES. THE HP STATED THEY HAD ALREADY STARTED OVER AND COULD NOT DO THAT AGAIN. THE TSR ASSISTED THE HP WITH ENDING THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. A FOLLOW UP WAS DONE VIA PHONE CALL. THE REGISTERED NURSE (RN) STATED THEY SPOKE TO THE HP ON THE 15TH OF THIS MONTH AND WAS AWARE OF THE EVENT. THE RN DID NOT KNOW THE CAUSE OF THE ALARM BUT STATED THE HP HAS BEEN PERFORMING THERAPY SUCCESSFULLY SINCE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE