BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2834246 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05299
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS CONFIRMED BECAUSE THE PATIENT REPORTED DISCONNECTING FROM THE TRANSFER SET DURING THERAPY, WHICH IS USE ERROR THAT CAN CAUSE SYSTEM ERROR 2240 ALARMS. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 1 OF 5. THE HOME PATIENT (HP) STATED THE HC ALARMED SYSTEM ERROR 2240 IN DRAIN 1 OF 5. THE HP STATED THEY ACCIDENTALLY DISCONNECTED THEMSELVES FROM THE PATIENT LINE WHILE IN DRAIN 1. THE HP STATED WHEN THE HC ALARMED SYSTEM ERROR 2240 THEY RECONNECTED TO THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP POWER CYCLE THE HC. THE HC ALARMED SYSTEM ERROR 2367. THE TSR HAD THE HP POWER CYCLE THE HC AGAIN. THE HC PROCEEDED TO PRESS GO TO START. THE TSR ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES AND INFORM THE REGISTERED NURSE (RN) OF SYSTEM ERROR 2240. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(4) 2012, BAXTER (B)(4) FOLLOWED UP WITH THE HP. HE STATED HE DISCARDED THE SUPPLIES AND STARTED OVER WITH NEW SUPPLIES. NO SAMPLE/LOT # IS AVAILABLE. THE HP STATED HE FOLLOWED UP WITH THE NURSE TO INFORM THEM OF THE ALARM. THE HP STATED HE IS OK AND HAS CONTINUED WITH THERAPY.

    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 HOMECHOICE