BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2031933 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03747
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF THE CAREGIVER DROPPED THE PATIENT LINE IN DAY DWELL 2/2. CAREGIVER STARTED OVER WITH NEW SUPPLIES. 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. COMPLAINT WAS NOT CONFIRMED. NOT ENOUGH DATA ARE AVAILABLE WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. LABELING WAS REVIEWED FOR RELATED USE ERROR(S) AND THERE WERE NO ISSUES AND NO LABEL DEFICIENCY. 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.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING WITH GLOBAL TECHNICAL SERVICES (GTS), THE CAREGIVER STATED THAT THE PATIENT LINE FELL ON THE FLOOR. THE CAREGIVER STARTED OVER WITH NEW SUPPLIES. GTS HAD THE CAREGIVER COMPLETE THE INITIAL DRAIN AND BYPASS TO FILL 1 OF 4. 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 25 YR HOMECHOICE PRO