BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2240156 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11916
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 20, 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 LOW DRAIN VOLUME ALARM WAS CONFIRMED. THE ROOT CAUSE WAS AIR THE LINE WHICH IS A KNOWN CAUSE OF THE ALARM. THE LOT NUMBER WAS UNKNOWN, THEREFORE NO BATCH REVIEW WAS PERFORMED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT HAVING A LOW DRAIN VOLUME ALARM WITH THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE CARE GIVER (CG) STATED THAT SHE JUST GOT OUT OF THE HOSPITAL THE PREVIOUS DAY AFTER HAVING PROBLEMS WITH HER CATHETER. THE CG NOTED THAT SHE SAW AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS (PD) NURSE REGARDING THE REPORTED EVENT. THE NURSE STATED THE HP WAS IN THE HOSPITAL TO HAVE HER CATHETER REMOVED. THE NURSE STATED HP'S CATHETER MOVED WHICH CAUSED PROBLEMS WITH HER PD THERAPY. THE NURSE STATED THE HP HAS BEEN MOVED TO HEMODIALYSIS BUT WAS EXPECTED TO RETURN TO PD THERAPY IN 3 WEEKS. PER THE NURSE, THE HP WAS DOING WELL ON HEMODIALYSIS.

    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