BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 1201228 · Received October 20, 2008

    Report

    Report Number
    1423500-2007-00075
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 12, 2006
    Report Date
    October 16, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 16 2007. EVALUATION RESULTS: THIS COMPLAINT WAS CONFIRMED IN THE LAB FOR CUT/SLICED TUBING. THE SPECIFIC ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. NO ABERRANCIES WERE NOTED DURING THE MANUFACTURING BATCH REVIEW. HOWEVER, RENAL PRODUCT SURVEILLANCE AND QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING/QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE. NO FURTHER ACTION HAS BEEN TAKEN RELATIVE TO THIS MATTER.

    Description of Event or Problem · 1

    BAXTER CANADA REPORTED THAT THE PATIENT LINE TUBING OF A SPIKE HOME CHOICE CASSETTE BROKE AWAY FROM THE CASSETTE DURING USE ON A PATIENT. BAXTER QA SPOKE TO THE PATIENT'S NURSE AND WERE TOLD BY THE RN THAT THE BREAK OCCURRED AT THE END CONNECTED TO THE CASSETTE AND NOT AT THE END CONNECTED TO THE PATIENT. THE NURSE REPORTS THE TUBING APPEARED TO HAVE STRESS CRACKS AT THE POINT OF BREAKAGE. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED FROM INTERNATIONAL AFFILIATE STATED THAT THAT THE TUBING DISCONNECTED DURING THERAPY, AND NO ABNORMALITY WAS NOTED WITH THE HOMECHOICE MACHINE. THE PATIENT WAS STILL USING THE HOMECHOICE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION H06E12016

    Patients

    Seq Age Sex Outcome Treatment
    1