BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3232784 · Received July 18, 2013

    Report

    Report Number
    1416980-2013-18806
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) RECEIVED A SYSTEM ERROR 2267 (AIR AND FLUID IN SET) ALARM. THIS OCCURRED ON A HOMECHOICE (HC) DEVICE DURING DWELL EIGHT OF TEN. THE HEATER BAG HAD SOLUTION IN IT, BUT ONLY ONE OF THE TWO SUPPLY BAGS HAD SOLUTION INSIDE. BOTH SUPPLY BAGS WERE CONNECTED TO THE TWO WHITE CLAMPED LINES. NO OBVIOUS SIGNS OF A LEAK WERE OBSERVED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER IN CLEARING THE ALARM. THE HP WAS TO FINISH WITH MANUAL SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333020 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR HOMECHOICE