BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2170413 · Received July 20, 2011

    Report

    Report Number
    1423500-2011-09244
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CHECK YOUR POSITION ALARM WAS CONFIRMED. THE CAUSE IS AIR IN THE PATIENT LINE. A SAMPLE WAS NOT SENT IN AND A LOT NUMBER WAS NOT PROVIDED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE NURSE REGARDING THE REPORTED EVENT. THE NURSE STATED IT WAS UNKNOWN WHAT MAY HAVE CAUSED THE AIR IN LINES TO OCCUR. PER THE NURSE, THERE WERE NO ALLEGATIONS AGAINST ANY OF THE PATIENT'S SUPPLIES. THE NURSE STATED THE SAMPLES WERE DISCARDED AND THE LOT NUMBER WAS UNKNOWN. SHE ALSO STATED THAT THE PATIENT WAS DOING WELL ON THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A "CHECK YOUR POSITION ALARM" WAS NOT CONFIRMED. THE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CHECK YOUR POSITION ALARM WITH THE HOMECHOICE (HC) MACHINE DURING FILL 1 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CARE GIVER (CG) TO REMOVE THE TAPE OFF THE CATHETER, CHECK THE PATIENT LINE FOR KINKS, CLOSED CLAMPS OR FLUID / AIR IN THE LINES. THE CG STATED THE LINE WAS FULL OF FLUID AND AIR. THE TSR THEN ADVISED THE CG TO END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 40 YR HOMECHOICE