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BMU 40

Maquet Cardiopulmonary AG · Model Y-Datacable kit (Lemo auf 2 x DE9f) · UDI-DI 04037691676203

DRY Prescription

510(k) clearances

5,039

Adverse events (8 deaths)

Recalls

Facilities

Description

Y-Datacable kit (LEMO 2 x DE9 female) incl. adaptor kit. RS232-Isolator 4KV. The blood monitoring unit BMU 40 is used to monitor the patient’s key blood levels during extracorporeal circulation. On the basis of the blood levels, the user can immediately adjust the settings of the equipment being used, thereby increasing patient safety.

Recalls

Date	Firm	Reason
2025-05-28	Terumo Cardiovascular Systems Corporation	Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following change
2025-03-03	Terumo Cardiovascular Systems Corporation	During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a ye
2020-09-30	Maquet Cardiovascular Us Sales, Llc	The 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 designed with a short
2018-06-26	Terumo Cardiovascular Systems Corporation	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
2018-06-26	Terumo Cardiovascular Systems Corporation	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
2016-03-14	Terumo Cardiovascular Systems Corporation	Specific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature val
2015-12-11	Terumo Cardiovascular Systems Corporation	Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette doe
2015-08-07	Terumo Cardiovascular Systems Corporation	Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
2014-05-09	Terumo Cardiovascular Systems Corporation	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 He
2013-02-27	Terumo Cardiovascular Systems Corporation	Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.