BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2190474 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10245
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT ISSUE WAS NOT CONFIRMED AS DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE ROOT CAUSE OF COMPLAINT WAS NOT DETERMINED AS DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THROUGH BAXTER'S AFTER HOURS CALL SERVICE. THE HOME PATIENT (HP) STATED THAT THE HOMECHOICE (HC) DID NOT DO AN INITIAL DRAIN AND MOVED INTO FILL 1. THE HP PRESSED STOP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP PRESS DOWN ARROW TO MANUAL DRAIN AND THE HP MANUALLY DRAINED 2272ML. THE TSR HAD THE HP MOVE BACK TO STOPPED FILL AND PRESS GO TO RESUME FILL 1. THE HP WOULD SPEAK TO HIS RENAL NURSE ABOUT THE INITIAL DRAIN ALARM SETTING. THE HP COMPLETED DRAIN. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1