BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2170941 · Received July 21, 2011

    Report

    Report Number
    1423500-2011-09280
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 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). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. HOWEVER, BASED ON INVESTIGATION INFORMATION, THE CAUSE WAS DETERMINED AS AIR IN THE LINE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A LOW DRAIN VOLUME ALARM OCCURRED ON HOME CHOICE (HC) DURING USE INITIAL DRAIN. THE NURSE(RN) STATED THAT THERE WAS AIR IN THE LINE. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) EXPLAINED THAT THE RN WILL NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES, MAKING SURE THAT THE PATIENT LINE WAS FULLY PRIMED BEFORE CONNECTING THE HOME PATIENT (HP) . THE TSR THEN WALKED THE RN THROUGH ENDING THERAPY PROCEDURE. THERE WAS PATIENT INVOLVEMENT. 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 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HOMECHOICE