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Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

FDA product code DRY · Class 2 · Cardiovascular

126
Registered devices
5,047
Adverse events
40
Recalls
47
510(k) clearances

Devices with this code

CDI™ H/S Cuvette 3/8 x 3/8 with Extension — Terumo Cardiovascular Systems CorporationSystem M ® — SPECTRUM MEDICAL LIMITEDBMU 40 — Maquet Cardiopulmonary AGQuantum — SPECTRUM MEDICAL LIMITEDCDI OneView™ Monitoring System — Terumo Cardiovascular Systems CorporationSystem M ® — SPECTRUM MEDICAL LIMITEDQuantum ® System M ® — SPECTRUM MEDICAL LIMITEDQuantum ® System M ® — SPECTRUM MEDICAL LIMITEDCDI™ H/S Cuvette 1/2 x 1/2 — Terumo Cardiovascular Systems CorporationQuantum — SPECTRUM MEDICAL LIMITEDCDI OneView™ Monitoring System — Terumo Cardiovascular Systems CorporationQuantum — SPECTRUM MEDICAL LIMITEDTRILLIUM™ — MEDTRONIC, INC.CDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems CorporationCDI OneView™ Monitoring System — Terumo Cardiovascular Systems CorporationVirtual Kit Number — LivaNova Deutschland GmbHQuantum — SPECTRUM MEDICAL LIMITEDQuantum — SPECTRUM MEDICAL LIMITEDQuantum — SPECTRUM MEDICAL LIMITEDCDI™ H/S Cuvette 1/2 x 1/2 - Japan — Terumo Cardiovascular Systems CorporationCDI™ H/S Cuvette 3/8 x 3/8 — Terumo Cardiovascular Systems CorporationNA — MEDTRONIC, INC.Quantum — SPECTRUM MEDICAL LIMITEDBMU 40 — Maquet Cardiopulmonary AG

Recent recalls

DateFirmReason
2025-05-28Terumo Cardiovascular Systems CorporationDue to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additional
2025-03-03Terumo Cardiovascular Systems CorporationDuring some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data.
2020-09-30Maquet Cardiovascular Us Sales, LlcThe Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were de
2018-06-26Terumo Cardiovascular Systems CorporationH/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 w
2018-06-26Terumo Cardiovascular Systems CorporationH/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 w
2016-03-14Terumo Cardiovascular Systems CorporationSpecific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the b
2015-12-11Terumo Cardiovascular Systems CorporationTerumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the
2015-08-07Terumo Cardiovascular Systems CorporationInaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
2014-05-09Terumo Cardiovascular Systems CorporationThere is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with l
2013-02-27Terumo Cardiovascular Systems CorporationTerumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, an

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.