BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0609 HOMECHOICE AUTO PDSET 8-PRONG CASSETTE

    MDR report key: 1884298 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04980
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW-UP WITH THE CAREGIVER, IT WAS FOUND THE ISSUE WAS RESOLVED AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO SAMPLE WAS AVAILABLE; THEREFORE THE ISSUE COULD NOT BE CONFIRMED AND NO CAUSE WAS DETERMINED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUIRING ASSISTANCE WITH PRIMING ON THE HOMECHOICE (HC) UNIT. THE CARE GIVER (CG) STATED THAT THE HOME PATIENT (HP) IS USING DIFFERENT SOLUTION AND NOW SOLUTION IS COMING OUT OF THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) RECOMMENDED STARTING OVER WITH NEW SUPPLIES AND IF THE PATIENT LINE LEAKS AGAIN TO CONTACT THE REGISTERED NURSE (RN) AND BAXTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0609 HOMECHOICE AUTO PDSET 8-PRONG CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1