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	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility, the temperature difference situation was observed nearly four times a week for the month prior to reporting the issue.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the temperature displayed on the blood parameter monitor (bpm) was very different from the reading on the central control monitor (ccm).The bpm temperature reading switched from 17 degrees celsius to 31 degrees celsius instantly.It was stated that the unstable temperature readings appeared to affect other values.The team continued to use the device for the remainder of the case using blood gas analyzer values.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated blocks: d9, h3 and h6.The service repair technician (srt) could not duplicate the reported complaint.The monitor powered on and passed self-testing.The hematocrit (h/sat) passed service mode testing.The arterial blood parameter monitor (bpm) passed service mode testing.The arterial bpm passed intensity testing.The erasable electronically programmable read only memory (eeprom) contained zero critical errors.The srt placed the bpm in operate mode at two different times (before and after checking the internal 12v and sbc batteries) and the bpm was consistent with temperature readings in relation to its environment.The bpm thermistor was physically inspected and seemed to be in good working condition.During eeprom download and bpm intensity testing, it was noticed that the port connection to the test pc was intermittent on relaying information from the monitor to the pc screen.The srt replaced the printed circuit board assembly (i/o pcba) as a precaution.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• 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: 24456732
• Report Number: 1828100-2026-00032
• Device Sequence Number: 18643760
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190411
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/20/2026

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?: Device Returned to Manufacturer
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• 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