Recall Z-2750-2018 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be pro
| Date | Jun 26, 2018 |
| Status | Terminated |
| Reason | H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the device is powered on. This will not result in device inaccuracy, only Color Chip Test Failure which disables the H/Sat module. |
| Root cause | Vendor change control |
| Action | On June 26, 2018, the firm began notifying customers of the market withdrawal via telephone calls. The call alerted customers of the issue and scheduled an expedited return of affected CDI System 500 units to the firm's service depot so that Service Technicians may replace the affected H/SAT with a replacement H/SAT device. Customers then received a copy of the completed phone script by email along with a customer response form. Customers were asked to review the phone script, and complete and return the response form. Customers were also asked to assure that all users were notified of the i |
| Quantity | 128 in total |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, SC, TN, TX, WA, and WV. Foreign distribution to Middle East, Latin America, Europe, Japan, Canada, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 Terumo Cardiovascular Systems Corp., Jul 25, 2014 |