BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3946069 · Received July 21, 2014

    Report

    Report Number
    1416980-2014-23420
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. INTERNAL AND EXTERNAL VISUAL INSPECTIONS WERE PERFORMED AND PASSED. LEAK TESTING, CLAMP FUNCTION TESTING, CLEAR PASSAGE TESTING, AND A SIMULATED THERAPY WERE PERFORMED ON THE DEVICE WITH NO ISSUES NOTED. THE RESULTS OF THE SAMPLE ANALYSIS REVEALED THE DEVICE MET PRODUCT SPECIFICATIONS AND UPON CONCLUSION OF THE EVALUATION, THE DIRECT CAUSE OF THE REPORTED EVENT WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET). THIS OCCURRED DURING PERITONEAL DIALYSIS THERAPY WHILE THE PATIENT WAS CONNECTED TO THE DEVICE. THERE WAS NOTHING UNUSUAL FOUND DURING TROUBLESHOOTING THAT WOULD CAUSE OR CONTRIBUTE TO THE ALARM. THE PATIENT WAS TO FINISH THERAPY WITH MANUAL SUPPLIES. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424978 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HOMECHOICE