BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2032234 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03773
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE SERVICE HISTORY REVIEW, REVEALED NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF INCORRECT RE-PRIME PROCEDURE. THE CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE USE ERROR- PRESS GO AND BYPASS WHILE TRYING TO REPRIME THE PATIENT LINE. A LABELING REVIEW WAS PERFORMED AND FOUND CURRENT LABELING TO BE 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. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING AN INCOMPLETE PRIME WHICH OCCURRED ON THE HOMECHOICE (HC) PRIOR TO PATIENT CONNECTION. THE REGISTERED NURSE STATED THAT THEY PRESSED GO AND THEN STARTED BYPASSING BEFORE THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REALIZED WHAT THE NURSE WAS DOING. THE TSR EXPLAINED THE SITUATION AND ADVISED TO START OVER WITH NEW SUPPLIES AS THE SUPPLIES WERE COMPROMISED. THE NURSE UNDERSTOOD THE EXPLANATION, ENDED THERAPY, AND WOULD START OVER WITH NEW SUPPLIES. 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1