| Class 2 Device Recall CDI Blood Parameter Monitoring System 500 | |
Date Initiated by Firm | March 14, 2016 |
Date Posted | March 25, 2016 |
Recall Status1 |
Terminated 3 on March 28, 2017 |
Recall Number | Z-1250-2016 |
Recall Event ID |
73533 |
510(K)Number | K133658 |
Product Classification |
Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
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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. |
Code Information |
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 item number 137621) SN #'s: 3132 6004 CDI 500 MONITOR W/ ART/VEN/HS (500AVHCT item number 137630) SN #'s: 1304 1405 1905 2105 2224 2495 2580 2633 2867 3332 3404 4224 5076 5096 8000 8002 8023 500AVHCT MTR - CON LOANER (500AVHCTCL item number 411168) SN #'s: 1036 1043 1046 1149 1151 1152 1264 1353 1354 1381 1389 1393 1624 1954 2074 2126 6016 6041 6042 6046 500AVHCT MONITOR-LOANER (500AVHCTL item number 372200) SN #'s: 1015 1038 1466 2035 7081 500AVHCT MONITOR - TRIAL (500AVHCTTK item number 476543) SN #'s: 1953 3425 500AV MONITOR - LOANER (500AVL item number 418520) SN #: 2023 Outside US. BPM SENSOR HEAD ASSY CDI 500 item number 145891 SN#'s: B019781 B019782 B019783 B019784 B019790 B019791 B019792 B019793 B019794 B019795 B019796 B019797 B019798 B019799 B019800 B019802 B019803 B019804 B019805 B019806 B019807 B019808 B019809 B019810 B019811 B019812 B019813 B019814 B019815 B019816 B019848 B019849 B019850 B019851 B019869 B019870 B019871 B019872 B019876 B019877 B019878 B019879 B019880 B019881 B019882 B019883 B019884 B019885 B019886 B019887 B019888 B019889 B019890 B019901 B019917 B019918 B019919 B019920 B019921 B019937 B019938 B019939 B019940 B019941 B019947 B019948 B019949 B019950 B019951 B019957 B019958 B019959 B019960 B019961 B019962 B019963 B019965 B019966 B019967 B019968 B019969 B019970 B019971 B019978 B019979 B019980 B019981 B019982 B019983 B019984 B019985 B019986 B019987 B019988 B019989 B019990 B019991 B019997 B019998 B019999 B020000 B020001 B020003 B020005 B020007 B020008 B020010 B020013 B020014 B020015 B020020 B020021 B020022 B020023 B020024 B020025 BPM SENSOR HEAD ASSY ROHS item number 858828 SN #'s: B021130 B021131 B021132 B021133 B021134 B021139 B021141 B021142 B021144 B021145 B021146 B021147 B021148 B021149 B021199 B021201 B021202 B021211 B021213 B021215 B021219 B021220 B021221 B021234 B021235 B021236 B021237 B021238 B021239 B021254 B021259 B021260 B021261 B021262 B021264 B021265 B021266 B021267 B021268 B021270 CDI 500 MONITOR WITH ART/HS (500AHCT item number 137613) SN #'s: 1899 1948 2473 3030 3078 3230 3339 3587 3623 8004 8005 8014 8015 8017 8019 8021 8025 8027 8029 8030 8032 8033 8035 8035 8036 8038 8055 8056 8056 8059 CDI 500 MONITOR W/ ART/VEN/HS (500AVHCT item number 137630) SN #'s: 1271 1902 2515 2784 3544 4018 4342 5147 5148 5303 8001 8022 8024 8037 8039 8046 8063 8064 8065 8066 8067 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Rd Ann Arbor MI 48103-9586
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For Additional Information Contact | Terumo CVS Customer Service 800-521-2818 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 in Commerce | 222 |
Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DRY
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