BEUDAMED
    FDA Recall Terminated

    CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

    Recall: Z-0001-2017 · Initiated December 11, 2015

    Recall

    Recall Number
    Z-0001-2017
    Event Number
    75118
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    3000204839
    Product Code
    DRY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 11, 2015
    Terminated
    October 26, 2016
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315

    Description

    CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

    Reason

    Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.

    Action

    Terumo (Planned Action) plans to execute the following steps as part of the correction activity: Notify all customers of the potential that a cuvette may disengage from the circuit (probe) leading to a "disconnect" message on the monitor. This notification will be performed via a Customer Notification Letter. For further questions, please call (410) 392-7277.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution.

    Quantity

    140,000 units