BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1153284 · Received September 8, 2008

    Report

    Report Number
    1423500-2008-00791
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED.

    Description of Event or Problem · 1

    IN 2008, THE HP'S CAREGIVER OF THE HOME PATIENT (HP) CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM AND SYSTEM ERROR 2367 ALARM DURING DRAIN 3 TO 6 WHILE USING THE HOME CHOICE DEVICE. THE PT LINE BECAME DISCONNECTED FROM THE TRANSFER SET BEFORE THE ALARM AND THEN THE HP RECONNECTED AFTER THE ALARM. THE TSR HELPED THE HP RECYCLE POWER AND CLEAR THE ALARM. THE TSR EXPLAINED THE ALARM. THE CAREGIVER WAS INSTRUCTED TO DISCARD SUPPLIES, FINISH THERAPY WITH MANUAL SUPPLIES AND CONTACT THE NURSE. EIGHT DAYS LATER, DURING A FOLLOW-UP CALL, THE PERITONEAL DIALYSIS NURSE STATED THE HP WAS DIAGNOSED WITH PERITONITIS. THE HP PRESENTED WITH ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE HP WAS NOT HOSPITALIZED AND HAD NO EXIT SITE OR TUNNEL INFECTION. ACCORDING TO THE NURSE, THERE WAS MOST LIKELY A BREAK IN ASEPTIC TECHNIQUE. THE HP WAS RETRAINED ON PROPER PROCEDURE. THE HP'S EFFLUENT WAS CULTURED. ACCORDING TO THE NURSE, THE HP IS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention