BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3222692 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18115
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. AS A RESULT, THE CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERITONEAL DIALYSIS (PD) THERAPY, A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) AND SE 2367 (FAIL SAFE SHUT DOWN) ALARM OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING DWELL 4 OF 5. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO RECYCLE THE POWER AND CLEAR THE ALARM. THE TSR EXPLAINED THE ALARM AND THE HP WOULD DRAIN AND FILL MANUALLY. THE HP WOULD DWELL AND DRAIN AS THE LAST FILL VOLUME (LFV) EQUALED 0ML AND THE ULTRA FILTRATION (UF) EQUALED -1219ML. THE HP WILL CALL THEIR PD NURSE (PDN) AND ADVISE THE PDN OF THE AIR DETECT ALARM WHICH OCCURRED WHILE BEING CONNECTED. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323757 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