BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2771710 · Received October 4, 2012

    Report

    Report Number
    1416980-2012-01518
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS USE ERROR - OPEN CLAMP. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 6 OF 8. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTING AND NO PATIENT EXTENSION LINES WERE IN USE. THE PATIENT DID NOT DISCONNECT PRIOR TO THE ALARM. ALL OF THE BAGS WERE PROPERLY CONNECTED. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE HOME PATIENT (HP) CHECKED THE LINES AND BAGS AND FOUND THE UNUSED SUPPLY LINE CLAMP WAS OPEN. THE HP CYCLED THE POWER TO CLEAR THE ALARM, WHICH WAS FOLLOWED BY A SYSTEM ERROR 2367. THE HP THEN ENDED THERAPY AND DISCONNECTED USING ASEPTIC TECHNIQUE. THE HP REMOVED THE CASSETTE. THE CARE GIVER WOULD NOTIFY THE HP'S PERITONEAL DIALYSIS REGISTERED NURSE. PROPER PROCEDURES WERE REVIEWED WITH THE PATIENT, AND THERE WERE NO SAMPLES AVAILABLE. 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
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE