BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2233876 · Received September 6, 2011

    Report

    Report Number
    1423500-2011-11694
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 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 WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE, A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AIR IN THE PATIENT LINE DURING A CHECK PATIENT LINE ALARM WAS CONFIRMED. LABEL REVIEW WAS COMPLETED AND FOUND TO BE SUFFICIENT AND ACCESSIBLE TO THE COMPLAINT. 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).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING AIR IN THE LINE DURING A CHECK PATIENT LINE ALARM DURING THE INITIAL DRAIN ON THE HOME CHOICE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TROUBLESHOOT AND CHECK THE LINES FOR FIBRIN OR AIR. THE HP STATED THAT THERE WAS AIR IN THE PATIENT LINE. THE TSR RECOMMENDED THAT THE HP END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR WALKED THE HP THROUGH ENDING THERAPY AND THE HP WOULD START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(4) 2011 REGARDING THE CHECK PATIENT LINE ALARM WITH AIR IN THE TUBING. THE HP STARTED OVER WITH NEW SUPPLIES AND RESUMED THERAPY. THE HP FOLLOWED UP WITH HIS PERITONEAL DIALYSIS NURSE (PDRN) ABOUT THE AIR IN THE LINE. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 67 YR HOMECHOICE