BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2042642 · Received April 6, 2011

    Report

    Report Number
    1423500-2011-04163
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THIS REPORT FOR A LEAK WAS CONFIRMED IN THE LAB. A VISUAL INSPECTION WAS PERFORMED AND A CRACK WAS NOTED IN THE CORNER END OF THE CASSETTE. THE CASSETTE WAS LOADED ONTO THE HOMECHOICE MACHINE AND A FUNCTIONAL INSPECTION WAS PERFORMED. A BATCH REVIEW WAS PERFORMED AND NO EXCEPTIONS OR NONCONFORMANCE HAVE BEEN FOUND. A ROOT CAUSE WAS NOT IDENTIFIED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510K 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 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A NURSE CONTACTED BAXTER (B)(4) AND REPORTED THAT WHEN THE PATIENT HAD FILLED THE CASSETTE (FILLED THE TUBES) AND WAS GOING TO START THERAPY, THE TREATMENT SOLUTION HAD LEAKED OUT FROM THE DOOR OF THE HOMECHOICE MACHINE WHERE THE CASSETTE WAS PLACED. THE OCCURRENCE DATE IS UNKNOWN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    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 - SINGAPORE S10A13108

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE