BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1650827 · Received April 5, 2010

    Report

    Report Number
    1423500-2010-00388
    Event Type
    Malfunction
    Date Received
    April 5, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT DISCARDED THE SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING DWELL 3 OF 4. THE CARE GIVER (CG) STATED THAT ONE OF THE SUPPLY BAGS FELL ON THE FLOOR AND THE SPIKE IS NOT IN THE BAG ANYMORE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE CG THE REASON FOR THE ALARM AND THEN EXPLAINED TO THE CG TO CYCLE THE POWER OFF/ON TWICE AND THEN THROW ALL OF THE USED SUPPLIES AWAY. THE TSR THEN ASSISTED THE CG TO DISCONNECT THE HOME PATIENT (HP) USING PROPER DISCONNECT PROCEDURES. THE TSR THE EXPLAINED TO THE CG TO MAKE SURE THE HP IS DRAINED FIRST BEFORE BEING FILLED AGAIN AND TO MAKE SURE THE SON IS AWARE OF THE PROBLEM TONIGHT. THE CG STATED THAT THE SON IS THE NORMAL CG AND THAT HE IS THE ONE THAT SETS THE HP UP FOR THERAPY AND DISCONNECTS THE HP IN THE MORNING. THE HC UNIT WAS OPERATIONAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR