BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2000677 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02420
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 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 REPORT FOR AN OVERPRIME-LEAK OUT OF THE PATIENT LINE WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. THE ROOT CAUSE IS THAT THE PATIENT STACKED THE SOLUTION BAGS ON TOP OF EACH OTHER DURING THERAPY. THE RESULTS OF A LABEL REVIEW FOUND LABELING TO BE ADEQUATE FOR THE USE 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 EVENT 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. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED THAT FLUID IS COMING OUT OF THE PATIENT LINE DURING PRIMING. THERE WERE MULTIPLE BAGS STACKED ON THE HEATER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HOME PATIENT (HP) THAT IS THE CAUSE OF EXCESS FLUID COMING FROM THE PATIENT LINE DURING PRIME. THE HP WILL REMOVE SUPPLY BAGS FROM THE HEATER TRAY. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011. ACCORDING TO THE NURSE SHE WAS NOT AWARE OF THIS EVENT; HOWEVER, THE PATIENT HAS BEEN SEEN SINCE AND HAS RESUMED THERAPY SUCCESSFULLY. PRODUCT SURVEILLANCE ADVISED THE NURSE THAT THE TSR EXPLAINED TO THE PATIENT TO NOT STACK THE BAGS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 56 YR HOMECHOICE