BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2153745 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08788
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 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 A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR 2240 AND SYSTEM ERROR 2367, WHICH OCCURRED DURING DRAIN 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AS THE CAREGIVER (CG) STATED THE LINE WAS NOT PRIMED WHEN THE HP CONNECTED AND PRESSED GO TO START INITIAL DRAIN. THE TSR HAD THE CG CYCLE POWER AND THE HC REALARMED WITH 2367. THE TSR HAD THE HP CYCLE POWER AGAIN AND THE ALARMS CLEARED. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE NURSE ON (B)(6) 2011. THE NURSE STATED THE FOLLOWING: THE EVENT HAD NOT BEEN REPORTED TO THEM AND THE PATIENT KNOWS NOT TO CONNECT WITHOUT PRIMING AND TO CALL THEM WHEN ISSUES ARISE. THEY HAD NOT SEEN OR HEARD FROM THE PATIENT SINCE THE EVENT SO THEY WERE UNSURE HOW THE PATIENT WAS WITH THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. BAXTER CONTACTED THE CAREGIVER ON (B)(6) 2011. THE CAREGIVER STATED THE FOLLOWING: NOTHING WAS SEEN WITH THE SUPPLIES THAT WOULD HAVE CAUSED THE ALARM. NEW SUPPLIES WERE USED TO CLEAR THE ALARM. THE SAMPLE WAS DISCARDED AND THE BOX WAS USED FOR THERAPY SO A COMPANION SAMPLE AND LOT NUMBER WERE NOT AVAILABLE. NO PATIENT 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 33 YR HOME CHOICE