MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550; CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS

Model Number	550AHCT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) being used in conjunction with the neonatal extracorporeal membrane oxygenation (ecmo) suddenly shut down and then automatically restarted.After reconnecting the unit to the hematocrit saturation (h/s) probe and performing calibration, the data on the display was inaccurate.The carbon dioxide (co2) was 37 but the bpm displayed 46.The partial pressure oxygen (po2) was 322 but the bpm displayed 364.Another unexpected shutdown was followed by an automatic restart.The procedure was attempted using the previous calibration values; however, the gas data significantly deviated from the actual measurements.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: b5.
Event or Problem Description
Additional information was received that the displayed partial pressure of oxygen (po2) was 273 and the actual value was 238.The partial pressure of carbon dioxide (pco2) displayed value was 46 and the actual value was 37.The team verified the values using a blood gas analyzer.A recalibration was done using an analyzer.Although the device was set to use the previous calibration values, the data shifted after shutdown followed by two cycles of hardware shutdown and an automatic restart.The monitor was continued to be used as there was no replacement available.Since the patient was on extracorporeal membrane oxygenation (ecmo), the disposable sensor was also continued to be used.If there were any error messages, they were not identified because of the shutdowns.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 550
• Common Device Name: CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 24421900
• Report Number: 1828100-2026-00029
• Device Sequence Number: 5939923
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)230202
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 06/03/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/17/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD GAS ANALYZER.
• Patient Sex: Unknown