Recall Z-1734-2013 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
| Date | Jul 13, 2013 (initiated Feb 27, 2013) |
| Status | Terminated |
| Reason | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the |
| Root cause | Software design |
| Action | On 2/27/13, all consignees will receive a recall notification letter via Federal Express. Terumo CVS will correct all affected CDl Monitors. Correction to the devices will be completed concurrently with BPM replacements related to Z-2185/2189-11 RES 57194. Terumo continues to manufacture and ship devices affected by this recall. The long term corrective actions are associated with Recall# Z-2185/2189-11 RES 57194. As committed previously, we will re-notify all customers once we are ready to implement the fix for the BPM in the field. All units produced prior to the change in manufacturing w |
| Quantity | 3972 units since 4/26/12 |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of J |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972962 | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 3M Company, Nov 6, 1997 |