BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3222514 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18083
    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). AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2240 DURING THE DWELL STAGE IS CONFIRMED BECAUSE THE HOME PATIENT INDICATED THE SUPPLY BAG BECAME DISCONNECTED WITHOUT FALLING, WHICH IS A KNOWN CAUSE OF THIS TYPE OF ALARM. THE CAUSE FOR THE DISCONNECTION WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A SYSTEM ERROR (SE) 2240/2367 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. IT WAS FURTHER REPORTED THAT THE BAG BECAME DISCONNECTED DURING USE. A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CUSTOMER RECYCLE POWER AND THE ALARM CLEARED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY, ADVERSE EVENT, OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322438 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE