FDA Device recall Z-1250-2016
CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides conti…
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides conti… by Terumo Cardiovascular Systems, citing specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1250-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-14 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
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 consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
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 serviced devices. POTENTIAL HAZARD There have been no reported illnesses or injuries as a result of this issue. A user who is not aware that the CDI System 500 is displaying inaccurate temperature values may not manage patient temperature appropriately. Using inaccurate information to manage warming and cooling strategies for a procedure could result in prolonged time on bypass. It could also lead to unnecessarily aggressive temperature management, resulting in excessive hyper or hypothermia, with potential neurologic and organ dysfunction, or increased blood component damage. Inaccurate temperature measurement could also cause inaccurate measurements of other BPM values including potassium (K+), pO2, pCO2, and pH. The greater the temperature inaccuracy, the greater the degree of inaccuracy of these other BPM values due to the dependence of their algorithms on temperature for the calculations. Inaccurate measurement of these values could result in inappropriate patient management strategies being employed to address them with the potential to result in moderate patient injury.
Identifiers
| code_info | CDI 500 MONITOR WITH ART/HS (500AHCT item number 137613) SN #'s: 1190 1310 1346 1594 1647 1687 1693 1706 17…CDI 500 MONITOR WITH ART/HS (500AHCT item number 137613) SN #'s: 1190 1310 1346 1594 1647 1687 1693 1706 1769 1866 2028 2220 2242 2294 2311 2394 2460 2485 2506 2519 2644 2729 2776 2780 2821 2827 2858 2898 2900 3002 3092 3163 3184 3325 3513 3805 3808 3818 3823 3842 4061 4102 4109 5173 5264 5806 8003 8006 8007 8008 8009 8010 8011 8012 8013 8016 8018 8020 8026 8031 8034 8035 8040 8056 8060 500AHCT MTR - CON LOANER (500AHCTCL item number 411150) SN #'s: 1035 1060 1178 1198 1199 1228 1280 1325 1364 1535 1540 1545 1553 1557 1615 1689 1695 1743 1759 1850 1862 1942 1949 1988 2014 2147 2336 2359 2360 2557 2563 2609 3097 3337 3431 3433 3527 4059 4324 4327 5609 5698 5700 5701 5809 5820 5889 5894 5945 5991 7028 7029 7030 7034 7038 7061 500AHCT MONITOR - LOANER (500AHCTL item number 418538) SN #'s: 1283 2209 5546 CDI 500 MONITOR WITH ART/VEN (500AV ite |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1250-2016%22
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