BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2825061 · Received November 8, 2012

    Report

    Report Number
    1416980-2012-04429
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS COMPLAINT FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT WAS CONFIRMED BECAUSE IT WAS REPORTED AFTER GETTING THE ALARM, CUSTOMER CYCLED POWER, RELOADED THE SET, AND CONTINUED THERAPY WITH THE SAME SINGLE USE SUPPLIES, WHICH IS A USE ERROR/POOR ASEPTIC TECHNIQUE. THE CAUSE WAS UNDETERMINED. A LABELING REVIEW WAS PERFORMED IN RESPONSE TO THE USE ERROR IN THIS COMPLAINT, AND THE LABELING WAS FOUND TO BE ADEQUATE

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES THE ISSUE OF USE ERROR-REUSE OF SUPPLIES. DURING TROUBLESHOOTING FOR A RELOAD THE SET (RLS) 201 ALARM AND SYSTEM ERROR (SE) 2265 REPORTED BY A CUSTOMER WHICH OCCURED ON THE HOMECHOICE (HC) UNIT DURING USE, THE PATIENT WAS CONNECTED, IN DWELL 1. THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) STATED THAT THERE WAS A RLS 201 IN SETUP BUT THEY WERE ABLE TO CYCLE POWER, RELOAD THE SET, AND CONTINUED WITH THE SAME SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THIS SE IS ENDING THERAPY AND TO SETUP WITH NEW SUPPLIES. THE PR DN WILL SETUP WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 HOMECHOICE