BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 4121764 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33370
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED PROBLEM. A VISUAL INSPECTION WAS PERFORMED WITH NO ABNORMALITIES NOTED. LEAK TESTING, CLAMP FUNCTION TESTING, AND CLEAR PASSAGE TESTING WERE PERFORMED WITH NO ISSUES NOTED. A SIMULATED THERAPY WAS PERFORMED SUCCESSFULLY USING THE RETURNED DEVICE. UPON CONCLUSION OF THE EVALUATION, THE RETURNED SAMPLE WAS DETERMINED TO MEET VISUAL AND FUNCTIONAL PRODUCT SPECIFICATIONS. THE EVALUATION WAS UNABLE TO DUPLICATE THE REPORTED LEAK. A BATCH REVIEW WAS CONDUCTED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE, AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PERFORMING PERITONEAL DIALYSIS THERAPY EXPERIENCED A LEAK FROM THE PATIENT LINE OF THEIR CASSETTE. THE LEAK WAS REPORTED TO BE FROM THE PATIENT LINE "WHERE IT CONNECTS TO THE CATHETER." IT WAS REPORTED THAT DIANEAL SOLUTION LEAKED ONTO THE PATIENT. THIS EVENT WAS REPORTED TO OCCUR DURING PATIENT USE, AFTER THE PATIENT LINE WAS PRIMED AND BEFORE THE PATIENT WAS CONNECTED. THE PATIENT STARTED THERAPY OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED FOR THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601704 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H14G12053

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE