BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2182344 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09933
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 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 A LEAK WAS NOT CONFIRMED AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER 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 DISCARDED, BUT THE LOT NUMBER IS KNOWN. SINCE THE LOT NUMBER IS KNOWN, A BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING ASSISTANCE WITH PROBLEM CASSETTE; THIS OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT REVEALED THEY HAD THIS ISSUE FOR THE PAST FOUR NIGHTS IN A ROW. THEY STATED THEY HAD PROBLEMS WITH THE PRIMING OF THE CASSETTES AND IT WOULD LEAK. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE ADVISED THE PATIENT TO USE DIFFERENT CASSETTES FROM A NEW BOX. DURING A FOLLOW UP WITH THE HOME PATIENT REGARDING THE REPORTED PROBLEM, THEY STATED ALL OCCASIONS IN WHICH THE LEAK WAS FOUND WAS DURING THE SETUP DURING PRIME. THEY STATED THAT THE LEAK WAS FOUND BEFORE THE PATIENT CONNECTED FOR THERAPY, AND THEN THEY WOULD START OVER. THEY STATED SINCE THE START OF A NEW BOX, THEY HAVE NOT HAD FURTHER PROBLEMS. 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 H11D22011

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR HOMECHOICE