BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1813475 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02853
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 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). THIS COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE OF THE INCIDENT WAS UNDETERMINED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM (INDICATING AIR) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 1/5. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARMS AND HAD THE HP CYCLE POWER TWICE. THE TSR INSTRUCTED THE HP TO START OVER WITH NEW SUPPLIES. THE TSR ALSO INSTRUCTED THE HP TO NOTIFY THE NURSE WITHIN 24 HOURS ABOUT THE ALARM. THE CAUSE OF THE ALARM WAS UNDETERMINED. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. THERE WAS 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
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY/FKX FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1