BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 8-PRONG

    MDR report key: 1201844 · Received October 21, 2008

    Report

    Report Number
    1423500-2007-00105
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    December 20, 2006
    Report Date
    January 24, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON FEB 23 2007.

    Description of Event or Problem · 1

    BAXTER REPORTED A CASSETTE LEAK DURING PRIMING. PER FOLLOW UP RECEIVED FROM INTERNATIONAL AFFILIATE, THE LEAK HAPPENED A COUPLE OF TIMES. THE FIRST TIME THE LEAK OCCURRED, THE HOME PATIENT STOPPED THERAPY AND WENT TO THE CLINIC. THE PATIENT WAS GIVEN ANTIBIOTICS AS A PRECAUTION. AS THE LEAK OCCURRED AT THE PUMP PART OF THE CASSETTE, THE HOMECHOICE MACHINE WAS NOT THOUGHT TO BE THE CAUSE OF THE LEAK. THE HOME PATIENT IS STILL USING THE HOMECHOICE MACHINE. THE SECOND TIME THE LEAK OCCURRED, THE PATIENT STOPPED THERAPY AND RESUMED THERAPY WITH NEW CASSETTE. NO PATIENT INJURY WAS INDICATED IN THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 8-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1