BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2201250 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10567
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DWELL 1/2 WAS NOT CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. SAMPLE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DWELL 1 OF 2. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CLOSE ALL OF THE CLAMPS AND THE TRANSFER SET, CYCLE THE POWER ON THE HC TO THE SE 2367, AND CYCLE THE POWER ON THE HC AGAIN TO THE PRESS GO TO START DISPLAY. THE TSR EXPLAINED THE ALARMS AND THE REGISTERED NURSE (RN) STATED THAT THERE WERE NO SIGNS OF ANY LEAKS AND THE HP DID NOT DISCONNECT THAT NIGHT. THERE WERE NO WET LINES AND THE SPARE LINE CLAMPS WERE CLOSED OFF. THE TSR EXPLAINED TO DISCARD ALL OF THE SUPPLIES AND TO REPORT THE ALARMS TO THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) THE NEXT MORNING. THE HP WAS TO FINISH THAT NIGHT'S THERAPY WITH MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT 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 HOME CHOICE