BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 2074420 · Received May 2, 2011

    Report

    Report Number
    1423500-2011-05291
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT OF FEELING SICK WAS AMENDED BY THE REPORTING PHYSICIAN TO THE COMMON COLD. ON (B)(6) 2011, THE PATIENT WAS TRANSFERRED TO THE HOSPITAL BY AMBULANCE AND DIAGNOSED WITH COMMON COLD. DURING HOSPITALIZATION, AN UNSPECIFIED IV SOLUTION WAS ADMINISTERED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. DIANEAL-N PD-4 1.5 THERAPY WAS UNCHANGED AND ONGOING. MEDICAL HISTORY ALSO INCLUDED CARDIAC FAILURE. THE PHYSICIAN STATED THAT THE EVENT WAS NON-SERIOUS AND UNRELATED TO DIANEAL-N PD-4 1.5.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. 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 AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A CALL ON (B)(6) 2011 FROM A PATIENT'S FAMILY MEMBER WHO REPORTED THAT THE PATIENT FELT SICK DURING PERITONEAL DIALYSIS THERAPY AND WAS TRANSFERRED TO THE HOSPITAL BY AMBULANCE. THERE WAS NO ALLEGATION OF ANY DEVICE MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization HOME CHOICE CYCLER