BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3951187 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23707
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 ALARM (AIR IN LINE/SET). THIS EVENT OCCURRED DURING THE INITIAL DRAIN CYCLE OF PERITONEAL DIALYSIS THERAPY WHILE THE PATIENT WAS CONNECTED. THE PATIENT STATED THAT THEY WERE UNSURE IF THE PATIENT LINE HAD BEEN PROPERLY PRIMED BEFORE CONNECTING OR IF THEY HAD INITIATED THERAPY BEFORE CONNECTING TO THE HOMECHOICE. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT IN CLEARING THE ALARM AND ADVISED THE PATIENT TO RESTART THERAPY WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427530 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE