BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2844815 · Received November 26, 2012

    Report

    Report Number
    1416980-2012-05806
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT IS FOR A REPORT OF A LEAK ISSUE IS CONFIRMED BECAUSE IT WAS REPORTED DUE TO POWER FAILURE PATIENT DISCONNECTED SELF WITHOUT FOLLOWING PROPER EMERGENCY DISCONNECT PROCEDURE CAUSING THE FLUID TO LEAKED ON THE FLOOR DURING THE LAST FILL. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4).THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOME PATIENT (HP) WITH A POWER FAILURE IN THE LAST FILL ON A HOME CHOICE (HC), FILL VOLUME (FV)=2476ML AND THE HP DISCONNECTED AND FLUID WAS LEAKING ON THE FLOOR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY AS THE HP HAD DISCONNECTED. THE HP MAY NOT HAVE BEEN CONNECTED WHEN THE HP WAS DOING THE LAST FILL, ACCOUNTING FOR THE FLUID LEAK ON THE FLOOR. THE HP WOULD CALL BACK IF ANY PROBLEMS AND WOULD DRAIN/FILL MANUALLY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 48 YR HOMECHOICE