BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2010095 · Received March 8, 2011

    Report

    Report Number
    1423500-2011-02843
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 6, 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 REPORT FOR A PATIENT CONTAMINATING THE PATIENT LINE WHEN HE DISCONNECTED CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION AGAINST A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REQUESTED THERAPY ASSISTANCE DURING DWELL 1 OF 1 AS THE HOME PATIENT (HP) STATED THAT THEY HAD DROPPED THE PATIENT LINE WHILE DISCONNECTING. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH ENDING THE THERAPY SO THE HP COULD START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE ATTEMPTED TO CONTACT THE NURSE ON (B)(6) 2011. A DETAILED MESSAGED WAS LEFT NOTIFYING THE NURSE OF THE EVENT AND ADVISING HER TO CALL SHOULD SHE HAVE ANY QUESTIONS OR ISSUES TO REPORT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO FURTHER INFORMATION IS AVAILABLE.

    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 17 YR HOMECHOICE CYCLER