BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2043455 · Received April 7, 2011

    Report

    Report Number
    1423500-2011-04172
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    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). A COMPANION SAMPLE IS BEING RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. ROOT CAUSE WAS UNDETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN VOLUME (LDV) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN. (DRAIN VOLUME = 26ML). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP INTO FILL 1. THE HP NOTICED AIR IN THE PATIENT LINE. THE TSR ASSISTED TO STOP THERAPY FOR THE HP. THE HP WOULD REPLACE THE SET UP AND RESTART WITH NEW BAGS AND CASSETTE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP, THE HOME PATIENT STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES NO FURTHER ISSUES WERE FOUND. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HC CYCLER