BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3802761 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14979
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, INITIATING THERAPY PRIOR TO CONNECTING TO THE DEVICE IS A KNOWN CAUSE OF THIS ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿ WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR WHEN AND HOW TO CONNECT TO THE DISPOSABLE SET AND INSTRUCTS THE USER TO CONNECT THE TRANSFER SET TO THE PATIENT LINE PRIOR TO STARTING THE INITIAL DRAIN. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON A HOMECHOICE (HC) DEVICE DURING THE SECOND DWELL CYCLE OF AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. TROUBLESHOOTING REVEALED THAT THE HOME PATIENT (HP) PRESSED GO BEFORE CONNECTING TO THE DEVICE. THE HP THEN PROCEEDED TO CONNECT TO THE MACHINE. A TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROPER PROCEDURES WITH THE HP. THE TSR INSTRUCTED THE HP TO COMPLETE THERAPY WITH NEW SUPPLIES OR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280800 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HOMECHOICE