BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3090415 · Received May 2, 2013

    Report

    Report Number
    1416980-2013-11141
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). . THE SYSTEM ERROR 2240 ALARM WHERE THE USE ERROR - PATIENT DISCONNECTED FROM SET, WHICH INTRODUCES AIR INTO THE SYSTEM AND CAUSES THE ALARM. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WAS NOT CONDUCTED. PER THE BAXTER HOMECHOICE OPERATOR'S MANUAL, USERS ARE INSTRUCTED HOW TO DISCONNECT AND RECONNECT PROPERLY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REPORTING A SYSTEM ERROR 2240 (AIR IN LINE) DURING DWELL 3 ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) STATED THEY DISCONNECTED TO USE THE RESTROOM AND THEN RE-CONNECTED. THE HP STATED THEY DID NOT CLOSE THE PATIENT LINE CLAMP OR THE TRANSFER SET BEFORE THEY DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE PROPER DISCONNECTION PROCEDURE. THE TSR HAD THE HP CYCLE POWER TO THE HOMECHOICE (HC) TO END THE THERAPY AND ADVISED THE HP TO CONTACT THE REGISTERED NURSE (RN) ABOUT THE POSSIBLE EXPOSURE TO UNSTERILE AIR. THE HP UNDERSTOOD AND WAS CALLING THE RN IN THE MORNING. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS 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
    191987 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE