BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141769 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08415
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 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). A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FOR A CHECK PATIENT LINE ALARM WAS NOT CONFIRMED AND THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE DEVICE WAS REQUESTED BUT WAS NOT AVAILABLE. 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 NO TRENDS WERE IDENTIFIED. BAXTER WILL CONTINUE TO MONITOR THE PRODUCT LINE TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A CHECK PATIENT LINE ALARM ON THE HOME CHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THERE WAS AIR IN THE LINE. GTS ASSISTED THE HP WITH ENDING THERAPY AND ADVISED THE HP TO SETUP WITH NEW SUPPLIES. PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HOME PATIENT, WHO STATED THAT AIR ENTERED THE SETUP BECAUSE THE PATIENT DID NOT PRIME ALL THE WAY AND HE DID NOT NOTICE UNTIL HE WAS CONNECTED. THE HP SAID HE DID NOT NOTIFY HIS NURSE AND PRODUCT SURVEILLANCE ADVISED CONTACTING THE NURSE WHEN AIR IS FOUND IN THE SETUP. NO SERIOUS 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 H11C18011

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HOMECHOICE