BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3090300 · Received May 2, 2013

    Report

    Report Number
    1416980-2013-11133
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USE ERROR - REUSE OF SINGLE-USE SUPPLIES IS CONFIRMED BECAUSE IT WAS REPORTED IN THE EVENT DESCRIPTION THAT THE USER REUSED SAME SUPPLY BAG AFTER STARTING WITH NEW CASSETTE. THE ASSIGNABLE CAUSE CODE WAS UNDETERMINED BECAUSE EVEN THOUGH THE USE ERROR WAS IDENTIFIED, IT IS UNDETERMINED WHY THE DISPOSABLE WAS REUSED. A LABELING REVIEW FOUND THAT ALL PRINTED POUCHES FOR DISPOSABLE PRODUCTS INTENDED FOR SINGLE USE ARE LABELED WITH "THIS DEVICE IS INTENDED FOR SINGLE USE ONLY".

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2267 (AIR IN SET), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3. THE CUSTOMER STATED THE HC STARTED OVER FROM THE BEGINNING INSTEAD OF GOING TO DRAIN 3 ((B)(4)). THE HC IS IN FILL 1. THE FILL VOLUME (FV) WAS EQUAL TO 828ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) STOP FILL AND REVIEW ALARM LOG. THE TSR FOUND THAT THE HP HAD A SE 2267 FOLLOWED BY A SE 2367 OCCURRED. THE HP STATED THAT WHEN ERROR OCCURRED THEY CYCLED OFF/ON TO CLEAR ERRORS AND RESUMED SETUP WITH THE SAME SUPPLIES ((B)(4)). THE HP HAD REMAINED CONNECTED. IT WAS UNCLEAR IF THE PATIENT LINE CLAMP AND THE TRANSFER SET WERE CLOSED. THE TSR EXPLAINED ERROR MESSAGE AND ADVISED THE HP TO ALWAYS CALL FOR ASSISTANCE IN THE FUTURE IF ANY SE OCCURS. THE TSR ASSISTED WITH END OF THERAPY EARLY PROCEDURE AND ADVISED THE HP TO NOTIFY PERITONEAL DIALYSIS (PD) THE REGISTERED NURSE (RN) AS SOON AS POSSIBLE. ENDED THERAPY. THE SAMPLES ARE UNAVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191516 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOMECHOICE