BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE - 4 PRONG

    MDR report key: 1063836 · Received June 19, 2008

    Report

    Report Number
    1423500-2008-00519
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER REGARDING A SYSTEM ERROR 2240 DURING DWELL 4 OF 4 WHILE USING THE HOME CHOICE SYSTEM. THE SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE POWER AND SYSTEM ERROR 2367 WAS RECEIVED. THE TSR HAD THE HP TURN THE MACHINE OFF. WHEN ASKED IF ANY BAGS WERE DISCONNECTED, THE HP SAID NO. THERE WAS A LEAK IN THE TUBING SET. THE TSR INSTRUCTED THE HP TO DISCARD THE SUPPLIES AND DO A MANUAL EXCHANGE FOR THE LAST FILL. THE TSR INSTRUCTED THE HP TO CONTACT HIS NURSE ABOUT THE ALARM. THE MACHINE WAS OPERATIONAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE - 4 PRONG 78FKX FKX

    Patients

    Seq Age Sex Outcome Treatment
    1