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U.S. Department of Health and Human Services

Class 2 Device Recall CDI Blood parameter monitoring system 500 H/SAT

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  Class 2 Device Recall CDI Blood parameter monitoring system 500 H/SAT see related information
Date Initiated by Firm June 26, 2018
Create Date August 11, 2018
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-2751-2018
Recall Event ID 80530
510(K)Number K133658  
Product Classification Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
Product Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT
Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT

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 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 H011684  H011685  H011686  H011687  H011688  H011689  H011691  H011692  H011693  H011694  H011695  H011696  H011697  H011699  H011700  H011701  H011702  H011704  H011705  H011706  H011707  H011708  H011709  H011710  H011711  H011712  H011713  H011714  H011715  H011717  H011718  H011719  H011721  H011722  H011723  H011725  H011726  H011727  H011730  H011731  H011732  H011733  H011735  H011736  H011737  H011738  H011742  H011744  H011745  H011747  H011749  H011750  H011751  H011752  H011753  H011754  H011755  H011756  H011757  H011758  H011759  H011760  H011761  H011762  H011766  H011772  H011778  H011779  H011780  H011781  H011783  H011784  H011785  H011786  H011788  H011789  H011790  H011791  H011792  H011793  H011794  H011795  H011796  H011797  H011798  H011799  H011800  H011801  H011803  H011804  H011805  H011806  H011807  H011808  H011809  H011810  H011811  H011812  H011813  H011814  H011815  H011817  H011819  H011821  H024598  H024599  H024600  H024601  H024602  H024603  H024604  H024605  H024606  H024607  H024608  H024611  H024612  H024613  H024614  H024615  H024616  H024617  H024618  H024620  H024621  H024624  H024625  H024626  H024627  H024628  H024629  H024631  H024632  H024633  H024635  H024636  H024637  H024638  H024639  H024641  H024642  H024643  H024645  H024647  H024649  H024652  H024654  H024655  H024657  H024659  H024674  
Recalling Firm/
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 issue, and to prominently display the notice where all users may access it. To contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 (Monday  Friday, 8 a.m.  6 p.m. ET) Recall Fax: 1.734.741.6149
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = DRY and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.