FDA-Device2014-05-28Class II
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
Terumo Cardiovascular Systems Corporation
Hazard
There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing accep
Sold states
one customer in IA
Affected count
1
Manufactured in
6200 Jackson Rd, N/A, Ann Arbor, MI, United States
Products
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1634-2014Don't want to check this manually?
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