BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3040885 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08704
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A SYSTEM ERROR (SE) 2240 DETERMINED TO BE CAUSED BY USE ERROR DUE TO AN OPEN CLAMP. THE LABELING INSTRUCTS THE CUSTOMER TO ENSURE CLAMPS ON UNUSED LINES ARE CLOSED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) OCCURED DURING DWELL 3 OF 4 ON THE HOME CHOICE (HC). DURING TROUBLESHOOTING, THE HOME PATIENT (HP) REPORTED THEY HAD TWO SOLUTION BAGS CONNECTED AND THE CLAMP WAS OPEN ON THE UNUSED LINE. THE HP WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143773 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE