BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2972777 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04375
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2240 WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED ON THE HOMECHOICE (HC) DURING PERITONEAL DIALYSIS. THE EVENT OCCURRED DURING DWELL 1. THE HOME PATIENT (HP) STATED THAT THE LINES APPEARED TO BE NORMAL. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTING AND NO PATIENT EXTENSION LINES WERE IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. ALL OF THE BAGS WERE PROPERLY CONNECTED. THERE WERE NO OPEN CLAMPS ON UNUSED LINES. NOTHING UNUSUAL WAS NOTED ABOUT THE SUPPLIES AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE HP WOULD RESTART WITH NEW SUPPLIES. PROPER PROCEDURES WERE REVIEWED. 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
    75928 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HOMECHOICE