Recall Z-0001-2017 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
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.
| Date | Dec 11, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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. |
| Quantity | 140,000 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915265 | CDI(TM) H/S CUVETTE, MODIFICATION 3M Company, Jan 15, 1992 |