BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2936208 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02360
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 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. THE HOME PATIENT STATED THAT ONE BAG BECAME DISCONNECTED. THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT CONDUCTED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN SET) DURING DWELL 3 OF 5 ON THE HOMECHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND HAD THE HOME PATIENT (HP) CLOSE THE CLAMPS AND CYCLE THE POWER TO CLEAR BOTH THE SE 2240 AND THE SE 2367. THE HP HAD STATED A SOLUTION BAG FELL AND BECAME DISCONNECTED. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES OR FINISH WITH MANUALS. THE ALARM WAS CLEARED. THERE WAS PATIENT INVOLVEMENT BUT 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
    40240 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE