BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO

    MDR report key: 6250024 · Received January 13, 2017

    Report

    Report Number
    2025816-2016-00188
    Event Type
    Malfunction
    Date Received
    January 13, 2017
    Date of Event
    August 23, 2016
    Report Date
    September 15, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE FOUR POTENTIAL LOT# WAS PERFORMED. THE RESULTS RECORDED LOT# 3235901 (MFG. 04/2016) (B)(4) UNITS; LOT# 3251288 (MFG. 05/2016) (B)(4) UNITS; LOT#3293932(MFG. 07/2016) (B)(4) UNITS & LOT# 3297239 (MFG. 08/2016) (B)(4) UNITS WERE MFG. TESTED INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILDS. THE INVOLVED DIALYSIS TUBING SET-UP DEVICES AND TEGO CONNECTOR DEVICES WERE DISCARDED. THE EXACT CAUSE(S) OF THE REPORTED EVENTS, PRODUCT ISSUES ARE UNKNOWN. DEVICE(S) NOT RETURNED.

    Description of Event or Problem · 1

    INT'L. ((B)(6)) COMPLAINT RECEIVED CONCERNING INTERMITTENT OCCURRENCES OF LEAKAGE ISSUES WITH USE OF UNKNOWN DIALYSIS SET-UPS AND D1000 TEGO CONNECTORS. THE INFORMATION RECEIVED DESCRIBES THE ISSUES AS FOLLOWS " LEAKING BLOOD POST APPLICATION TO THE ENDS OF THE CENTRAL VENOUS ACCESS DEVICE OR SUPERCATH DEVICE, LEAKING AIR INTO THE HEMODIALYSIS MACHINE.." THE TEGO DEVICES WERE REMOVED, REPLACED & DISCARDED. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES. ADDITIONAL EVENT / USAGE INFORMATION ALTHOUGH REQUESTED WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31808 TEGO TEGO FPA ICU MEDICAL, INC. D1000 MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1