BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183527 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09971
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 10, 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). THIS COMPLAINT FOR OF USE ERROR WAS CONFIRMED AND THE CAUSE WAS IDENTIFIED AS THE PATIENT FAILING TO FOLLOW PROPER THERAPY STEP PROCEDURES. PATIENT STATED THAT THEY OBSERVED AIR IN THE PATIENT LINE AFTER FINISHING THE PRIME BUT DECIDED TO CONNECT ANYWAY. LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOME CHOICE (HC) AND THE PATIENT LINE WAS FULL OF AIR. THE HOME PATIENT (HP) REPORTED THAT SHE NOTICED THAT THE PATIENT LINE WAS FULL OF AIR WHEN THE PRIME FINISHED AND CONNECTED HERSELF ANYWAY. THE TSR EXPLAINED THAT THE HP WOULD NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR WALKED THE HP THROUGH ENDING THERAPY PROCEDURE, THEN ADVISED THE HP TO NEVER CONNECT IF THERE IS AIR IN THE LINE AFTER PRIME, BUT TO CALL BAXTER FOR RE-PRIME ASSISTANCE. THE HP ENDED THERAPY AND WOULD START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PD RN ON (B)(6) 2011 REGARDING THE AIR IN THE PATIENT LINE. THE PD RN STATED THE HP CONTACTED HER REGARDING THE AIR IN THE LINE. THE PD RN EXPLAINED THE PRIME AND RE-PRIME PROCESS WITH THE HP. THE PD RN STATED THE HP WAS COMING IN THAT DAY AND SHE WOULD CHECK WITH THE HP TO MAKE SURE SHE UNDERSTANDS TO COMPLETELY PRIME THE PATIENT LINE AND TO CONNECT AFTER THE SOLUTION IS AT THE TOP OF THE PATIENT LINE. THE PD RN STATED THE HP WAS CURRENTLY USING THE CYCLER FOR THERAPY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR HOMECHOICE