BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2990978 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05349
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 15, 2013
    Report Date
    September 21, 2015
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) IS NOT CONFIRMED BECAUSE DISPOSABLE SET WAS NOT RETURNED TO BAXTER FOR EVALUATION, LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW AND USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED EVENT. THE ASSIGNABLE CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 THERAPY ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) SAID SHE CYCLED THE POWER OFF AND ON, GOT THE SYSTEM ERROR 2367, CYCLED THE POWER AGAIN AND THE SYSTEM ERROR CLEARED. THE HP TOOK THE SUPPLIES OFF THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WAS UNABLE TO GO OVER THE SET UP WITH THE HP. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96160 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR