BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2002053 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02481
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 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 IS FOR A REPORT OF A USER ERROR. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USER ERROR/ MIS-USE. 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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

    DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE HOME PATIENT (HP) REGARDING THE POTENTIAL USE ERROR, THE HP STATED THAT SHE DID NOT REMEMBER THE EVENT; HOWEVER, SHE ADDED THAT SHE IS DOING FINE AND CONTINUING THERAPY. THE HP STATED THAT SHE IS AWARE OF THE PROPER PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK LINES AND BAGS ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING THE PRIME, THE HOME PATIENT (HP) REPORTED STARTING OVER WITH NEW LINES, BUT REUSED THE SAME BAGS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH NEW LINES AND BAGS. THE TSR ASSISTED THE HP TO CLEAR THE ALARM AND REMOVED THE CASSETTE. THERE WAS PATIENT INVOLVEMENT BUT 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 26 YR HC CYCLER