BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3073251 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10112
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 31, 2013
    Report Date
    March 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE PROPER DISCONNECT PROCEDURES WHEN TEMPORARILY DISCONNECTING FROM THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING SYSTEM ERROR 2240 (AIR IN TUBING) IN DRAIN 1 OF 4. THE PATIENT DID DISCONNECT PRIOR TO THE ALARM OR OBSERVED AIR. PROPER DISCONNECT PROCEDURES WERE NOT USED AND THE PATIENT RECONNECTED. THE EVENT OCCURRED DURING USE AND SOLUTION WAS PROVIDED OVER THE PHONE. THERE WAS NO INJURY OR MEDICAL INTERVENTION THAT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173905 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE