BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3895372 · Received June 25, 2014

    Report

    Report Number
    1416980-2014-20307
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AIR IN THE PATIENT LINE, INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE, WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOMECHOICE (HC) MACHINE, IT WAS REPORTED THAT TWO ¿BB SIZED¿ AND SPACED APART AIR BUBBLES WERE OBSERVED IN THE PATIENT LINE OF AN INTEGRATED APD SET WITH CASSETTE. THIS WAS NOTICED DURING PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE HOME PATIENT (HP) WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WAS UNABLE TO FIND ANYTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PRESENCE OF AIR. THE TSR HAD THE HP CYCLE THE POWER ON THE HC DEVICE AND END THERAPY. THE HP PLANNED TO COMPLETE THERAPY USING MANUAL SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370267 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR HOMECHOICE