Recall Z-1250-2016 · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Terumo Cardiovascular Systems Corporation

CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL 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

Date	Mar 25, 2016 (initiated Mar 14, 2016)
Status	Terminated
Reason	Specific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may cause inaccurate temperature measurement and inaccurate analyte display values on the CDI System 500 monitor. Terumo Cardiovascular Systems (Terumo CVS) received complaints of inaccurate temperature measurements for specific devices distributed since November 5, 2015. These include both new production devices and recently
Root cause	Nonconforming Material/Component
Action	Terumo sent an " URGENT MEDICAL DEVICE RECALL" notification dated March 14, 2016, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer. The Recall Notification has instructions for responding to the formal recall notification. If you have questions, contact Terumo CVS Customer Service: 800.521.2818 Customer Service Hours: Monday Friday 8 a.m. 6 p.m. ET
Quantity	222
Distribution	Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates.
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