BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2143327 · Received June 29, 2011

    Report

    Report Number
    1423500-2011-08466
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED. A ROOT CAUSE WAS NOT IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A RELATED REPORT, THE CUSTOMER REPORTED TO BAXTER'S TECHNICAL SERVICE CENTER THAT A LEAK WAS NOTED FROM THE CASSETTE DOOR OF THE HOMECHOICE (HC) UNIT. THIS EVENT OCCURRED PRIOR TO PATIENT CONNECTION. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) TO THE HOME PATIENT (HP) AS THE UNIT WAS BEING SWAPPED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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