BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2140017 · Received June 25, 2011

    Report

    Report Number
    1423500-2011-08357
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INCIDENT WAS DETERMINED TO BE DUE TO USE ERROR, THE PATIENT SUBMERGED THE DRAIN LINE INTO THE BUCKET. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USE ERROR IDENTIFIED IN THIS INCIDENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN VOLUME ALARM; WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DRAIN 4 OF 4. THE DRAIN VOLUME (DV) EQUALED 1868ML. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) PRESS STOP AND GO. THE HC WENT TO LAST FILL ON ITS OWN. THE TSR EXPLAINED THE POSSIBLE CAUSES FOR THE ALARM. THE HP HAD THE DRAIN LINE SUBMERGED INTO THE BUCKET. THE TSR EXPLAINED ABOUT THE AIR GAP. BAXTER CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (RN) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE PD RN STATED THAT THE HOME PATIENT (HP) HAS MENTIONED THIS REPORTED PROBLEM, AND THEY HAVE RECEIVED A RETRAINING REGARDING THE SETUP. THE PD RN STATED THEY HAVE CONTINUED THERAPY OKAY; THEY HAVE NOT HAD ANY OTHER PROBLEMS. 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 THE CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN V FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE