BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2233740 · Received September 3, 2011

    Report

    Report Number
    1423500-2011-11671
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 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). THE SAMPLE IS NOT AVAILABLE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS CONFIRMED DUE TO THE USE ERROR DESCRIBED BY THE PATIENT. THE HOME PATIENT HAD FAILED TO CONNECT TO THE CYCLER WHEN INITIAL DRAIN BEGAN, ALLOWING AIR IN THE LINE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) ON DURING USE DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THAT SHE DID NOT CONNECT THE PATIENT EXTENSION LINE BEFORE STARTING PRIME. THE HP CYCLED POWER TO CLEAR THE SE 2240 FOLLOWED BY SE 2367 AND ENDED THERAPY. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) REVIEWED PROPER SET UP PROCEDURES. THE TSR HAD THE HP DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVED THE CASSETTE. THE HP WILL NOTIFY THE PERITONEAL DIALYSIS REGISTERED NURSE AND START OVER WITH NEW SUPPLIES. 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 63 YR