BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1930665 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06956
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT INFORMATION WAS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED THAT THEY HAD GOTTEN THE ALARM A FEW TIMES IN RECENT THERAPIES AND WAS CONCERNED IF MACHINE WAS WORKING PROPERLY. THE HP ALSO STATED THAT THEY HAD ALWAYS BEEN CONNECTED AND DID NOT SEE ANY LEAKS FROM EITHER BAGS OR CONNECTIONS AT TIME OF THE ALARMS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND POSSIBLE CAUSES AND ADVISED THE HP THAT MACHINE WAS OKAY TO USE AND ADVISED TO CALL BAXTER WHEN ALARM OCCURS, SO THAT TROUBLESHOOTING CAN BE DONE.

    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 37 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)