BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3082993 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10674
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 7, 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). PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION OR IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 (AIR IN TUBING) ALARM OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3 OF 4 WITH THE HOME PATIENT (HP) CONNECTED. ONE OF THE SUPPLY BAGS HAD FALLEN AND HAD DISCONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HP TO CLEAR THE ALARM BY TURNING THE HC OFF AND ON AND THE HP WOULD FINISH WITH MANUAL BAGS. 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
    184142 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOME CHOICE