BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2936274 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02364
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED; PER THE COMPLAINT INFORMATION THE LIKELY CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG DISCONNECTED. DURING TROUBLESHOOTING, IT WAS NOTED THE SOLUTION BAG DISCONNECTED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT CONDUCTED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) DURING DWELL 2 OF 3 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO RECYCLE POWER, ALARMS CLEARED AND THE ALARMS WERE EXPLAINED. DURING TROUBLESHOOTING, IT WAS NOTED THE SOLUTION BAG DISCONNECTED. THE HP WOULD DISCARD THE SUPPLIES AND FINISH WITH MANUALS. THE HP WOULD CONTACT THE REGISTERED NURSE (RN) REGARDING THE AIR DETECT ALARM AND BEING CONNECTED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40345 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE