BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3142466 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14070
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE; THEREFORE, NO DEVICE ANALYSIS COULD BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) ON THE HOMECHOICE (HC) MACHINE DURING DWELL 1 OF 5. THE HP REPORTED BREAKING THE WRONG PORTION OF THE PLASTIC CONNECTION ON THE SUPPLY LINE WHICH RESULTED IN THE BAG BEING CONNECTED IMPROPERLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE PROPER SETUP PROCEDURES WITH THE HP AND INSTRUCTED TO RE-SET UP FOR THERAPY WITH ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244441 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HOMECHOICE