BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO

    MDR report key: 6271756 · Received January 23, 2017

    Report

    Report Number
    2025816-2016-00320
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Date of Event
    August 1, 2016
    Report Date
    October 20, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Removal / Correction Number
    2025816-09/01/2016-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED TEGO DEVICES WERE DISCARDED. THE EXACT CAUSE(S) OF THESE EVENT(S) /PRODUCT ISSUE ARE UNKNOWN. HOWEVER, PREVIOUS INVESTIGATIONS OF THIS REPORTED TEGO LOT# HAVE BEEN CONDUCTED. IDENTIFIED A POTENTIAL FOR LEAKAGE WHEN THE TEGO IS CONNECTED TO THE DIALYSIS TUBING DURING THE HEMODIALYSIS TREATMENT. ICU MEDICAL INC. HAS IDENTIFIED THE POTENTIAL RISK OF LEAKING WITH CERTAIN TEGO® CONNECTOR DEVICES. THE POTENTIAL FOR LEAKAGE COULD EXIST WHEN THE TEGO IS CONNECTED TO THE DIALYSIS TUBING DURING THE HEMODIALYSIS TREATMENT, AND MAY LEAD TO BLOOD LOSS. ICU MEDICAL HAS RECEIVED REPORTS ASSOCIATED WITH THIS ISSUE. ICU MEDICAL IS RECALLING THOSE SPECIFIC LOTS THAT COULD POTENTIALLY CONTAIN THIS CONDITION. THERE HAVE BEEN NO REPORTS OF ADVERSE PATIENT CONSEQUENCES AS A RESULT OF THIS ISSUE. DEVICE NOT RETURNED

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING FLOW/AIR IN THE LINES WITH USE OF UNSPECIFIED DIALYSIS SET-UPS WHERE D1000 TEGO CONNECTORS, LOT# 3255850 WERE IN USE. THE INITIAL INFORMATION RECEIVED REPORTS INTERMITTENT EVENTS OCCURRING IN (B)(6) WHERE "...TEGO PORT PROTECTORS THAT SEEM TO BE DEFECTED. THEY ARE ALLOWING A MICRO AIR-LEAK FOR OUR DIALYSIS PATIENTS DURING TREATMENTS ..." THE INVOLVED DEVICES WERE REMOVED, REPLACED AND DISCARDED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53313 TEGO TEGO FPA ICU MEDICAL, INC. D1000 3255850

    Patients

    Seq Age Sex Outcome Treatment
    1