BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192140 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10288
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 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 COMPLAINT FOR AIR IN TUBING WAS CONFIRMED. THE ROOT CAUSE WAS USE ERROR. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW 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 GLOBAL TECHNICAL SERVICE (GTS) REGARDING AIR IN THE PATIENT LINE ON THE HOME CHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED HE WAS ALREADY CONNECTED. THE HP STATED HE DID NOT OPEN THE CLAMP ON THE PATIENT LINE DURING PRIME SO THERE WAS A GAP OF AIR IN THE LINE. GTS ASSISTED THE HP TO END THERAPY AND ADVISED THE HP TO SET UP WITH NEW SUPPLIES. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE HP'S NURSE, WHO WAS NOT AWARE OF THE INCIDENT. THE NURSE SAID SHE WOULD CALL THE HP AND REVIEW PROPER PROCEDURES. THE NURSE SAID THERAPY WAS GOING FINE, AND THERE WERE NO COMPLICATIONS. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THE PATIENT WAS INVOLVED BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION 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