BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1962631 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00719
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    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 IS A REPORT OF A PATIENT ACCIDENTLY STARTING INITIAL DRAIN. THE PATIENT WAS NOT CONNECTED. THE CAREGIVER WOULD START OVER WITH NEW SUPPLIES. FOLLOW UP WAS DONE VIA PHONE. THE PATIENT HAD CONTINUED THERAPY WITH NO ISSUES AS A RESULT OF THIS EVENT. NOT ENOUGH DATA IS AVAILABLE WITHIN THE REPORT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE WAS NOT DETERMINED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR. 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.

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING NEEDING TO GET BACK TO CONNECT YOURSELF ON THE HOME CHOICE (HC) DURING USE. INITIAL DRAIN WAS STARTED IN ERROR. THE HOME PATIENT (HP) WAS NOT CONNECTED WHEN THEY STARTED THE INITIAL DRAIN. (B)(4) ASSISTED THE HP WITH ENDING THERAPY. THE CARE GIVER (CG) WOULD START OVER WITH NEW SUPPLIES. THE PATIENT WAS INVOLVED, BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. FOLLOW UP WAS DONE VIA PHONE; THE HP HAD CONTINUED THERAPY WITH NO ISSUES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HOME CHOICE CYLCLER