Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
FDA Recall Z-1943-2011 · Posted 2011-04-11
Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTY
Date Initiated2010-11-01
Date Terminated2012-04-17
Product Quantity468 monitors
Reason for Recall
Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.
Firm Action
On 11/1/2010, Terumo sent "URGENT MEDICAL DEVICE CORRECTION" notices to Chief Perfusionist, Department of Cardiovascular Surgery or Director of Operating Room Services. The letter informed the consignees about the incidents of the CDI 100 and 101 displaying inaccurate values. The letter states that when a displayed value is significantly different from expectations based on the clinical situation, the user should verify the accuracy by independent means before treating. The letter included "Caution" stickers that were to be applied to the CDI system operators manual.
Root Cause
Device Design
Distribution Pattern
US, India, Colombia, Taiwan, Venezuela, Vietnam, Puerto Rico, Malaysia, Sri Lanka, Brazil, Indonesia, Pakistan, Chile, Germany, Hong Kong, Japan, AE, Singapore, Austria, Belgium and Thailand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.