BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3973216 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25043
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. HOWEVER, THE HOME PATIENT (HP) REPORTED NOT TIGHTENING THE CONNECTION PROPERLY TO THE SUPPLY BAG. 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 INSTRUCTS THE USER TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING THERAPY. THE GUIDE ALSO PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY CONNECTING THE SOLUTION BAGS. A 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 SET / LINE) OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING FILL ONE. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE HP INFORMED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT THEY DIDN¿T GET THE HEATER BAG CONNECTED TIGHTLY AND IT BECAME DISCONNECTED. THE TSR EXPLAINED THE ALARM AND INSTRUCTED THE HP TO CYCLE THE POWER ON THE HC TO CLEAR THE ALARM. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. 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
    450492 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE