BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2055589 · Received April 14, 2011

    Report

    Report Number
    1423500-2011-04484
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 23, 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). PER THE COMPLAINT INFORMATION, THE CAUSE OF THE REPORT IS USER ERROR / MIS-USE. LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IDENTIFIED IN THIS REPORT. 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    DURING FOLLOW UP FOR A CHECK HEATER LINE ALARM, BAXTER PRODUCT SURVEILLANCE ASKED THE HOME PATIENT (HP) IF THE HP RESUMED THERAPY AFTER BEING ADVISED TO START OVER WITH NEW SUPPLIES. THE HP SAID THAT HE RESUMED THERAPY AFTER GETTING A NEW BAG AND RE-ARRANGING THE SUPPLIES. THE HP KEPT TWO OF THE BAGS SINCE IT WAS THE BAG ON THE RED LINE WITH THE PROBLEM. THE HP SAID HE THREW THE RED BAG AWAY AND ADDED THE BAG ON THE BLUE LINE TO THE RED LINE. THE HP SAID HE ADDED THE NEW BAG TO THE BLUE LINE. PRODUCT SURVEILLANCE EXPLAINED THAT ALL SUPPLIES MUST BE CHANGED OUT TO KEEP THE SETUP STERILE AND THAT IT IS NOT RECOMMENDED TO SWITCH AROUND THE SUPPLIES AFTER THEY ARE SETUP. THE HP UNDERSTOOD. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO FURTHER INFORMATION IS AVAILABLE.

    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 25 YR HOMECHOICE