BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2900378 · Received January 7, 2013

    Report

    Report Number
    1416980-2013-00439
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2240 WAS CONFIRMED BASED, ON THE CUSTOMER REPORT. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 1. THE CARE GIVER (CG) STATED THE HC ALARMED AND WHEN HE CHECKED PATIENT LINE, THE CG NOTICED IT WAS DISCONNECTED FROM THE TRANSFER SET. IT WAS UNKNOWN HOW THE PATIENT LINE HAD BECOME DISCONNECTED. THE SUPPLIES HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE BAXTER TECHNICAL SERVICES REPRESENTATIVE (TSR) HAD THE CG CLOSE THE TRANSFER SET AND CYCLE THE POWER. A SYSTEM ERROR 2367 ALARMED. THE TSR HAD THE CG CLOSE ALL OF THE CLAMPS AND CYCLE THE POWER AGAIN TO GET TO "PRESS GO TO START". THE TSR ADVISED THE CG THAT AIR HAD ENTERED THE SETUP AND THAT HE WOULD NEED TO START OVER WITH ALL NEW SUPPLIES. THE TSR ADVISED THE CG TO INFORM THE PATIENT?S PERITONEAL DIALYSIS REGISTERED NURSE OF THE ALARM AND THE PATIENT LINE DISCONNECTING. THE CG WOULD START OVER WITH NEW SUPPLIES. THE HC WAS OPERATIONAL. PROPER PROCEDURES WERE REVIEWED, AND THERE WERE NO LOT NUMBERS OR SAMPLES AVAILABLE. 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
    6014 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HOMECHOICE