BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2904494 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00668
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 23, 2012
    Report Date
    December 23, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. THE PROBLEM OF USE ERROR, RE-USE OF SINGLE USE PRODUCT WAS CONFIRMED, BASED ON THE PATIENT'S REPORT. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED AS IT IS UNCERTAIN WHY THE PATIENT RE-USED SINGLE USE PRODUCT. A LABELING REVIEW HAS BEEN PERFORMED, FINDING THAT CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF THE USE ERROR IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING THERAPY ASSISTANCE WHICH OCCURRED ON THE HOMECHOICE (HC) DURING SETUP. THE CARE GIVER (CG) HAD ENDED THERAPY, AND THE HC WAS NOW ASKING FOR THE HOME PATIENT'S (HP) WEIGHT. THE SUPPLIES HAD BEEN REUSED AND THE PATIENT WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HP COULD NOT BE CONNECTED DURING THE SET UP PROCESS. THE TSR ADVISED THE CG TO DISPOSE OF THE CURRENT SUPPLIES AND START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON (B)(4) 2013. SHE STATED THAT THE PATIENT HAD NOT TOLD HER ABOUT THIS INCIDENT BUT THAT SHOULD WOULD SPEAK WITH THE PATIENT THE FOLLOWING DAY WHEN SHE CAME IN ABOUT RE-USING SUPPLIES. THE NURSE STATED THAT THE PATIENT'S THERAPY HAS BEEN GOING WELL AND NO ADVERSE EFFECTS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11124 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE