BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073271 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05227
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    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 IS FOR A REPORT OF A USER ERROR. IN EFFORTS TO REPRIME, THE PATIENT INSTEAD INITIATED THERAPY WHICH IS DONE BY PRESSED GO. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USE ERROR. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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). THE SAMPLE WAS NOT REQUESTED AS THIS IS A USE ERROR. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES(GTS) REGARDING ASSISTANCE WITH PRESSING GO WHILE TRYING TO REPRIME THE PATIENT LINE ON THE HOMECHOICE MACHINE(HC). THE HOME PATIENT STATED THEY DID NOT OPEN THE PATIENT LINE CLAMP DURING THE PRIME. THE PATIENT LINE DID NOT PRIME. THE HOME PATIENT THEN STATED THEY PRESSED STOP TO REPRIME THE PATIENT LINE, BUT PRESSED GO BY MISTAKE. THE HC ADVANCED TO THE INITIAL DRAIN. THE HOME PATIENT WAS NOT CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ADVISED THE HOME PATIENT(HP) TO END THERAPY AND START OVER WITH NEW SUPPLIES. NO 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 62 YR HC CYCLER