BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3082801 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10665
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE PATIENT AT HOME GUIDE, THE USER IS INSTRUCTED TO ENSURE ALL CLAMPS ARE CLOSED ON UNUSED LINES. 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

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 1 OF 3. THE HOME PATIENT (HP) STATED ONE OF THE UNUSED SUPPLY LINE CLAMPS WS OPEN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE THE POWER TO RECEIVE A SYSTEM ERROR 2367, THEN AGAIN TO GET TO "PRESS GO TO START", AT WHICH POINT THE HP DISCONNECTED AND REMOVED THE CASSETTE. THE TSR ASSISTED THE HP TO CLEAR THE ALARMS AND ADVISED THE HP TO CONTACT THEIR REGISTERED NURSE. 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
    183437 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE