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	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the potassium (k+) and carbon dioxide (co2) did not match the blood gas analyzer results and were fluctuating.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: d9.
Additional Manufacturer Narrative
Updated blocks: h3 & h6.The service repair technician (srt) powered on the monitor and it passed the self-test.The hematocrit (h/sat) passed service mode testing.The arterial blood parameter monitor (bpm) passed intensity testing.The erasable electronically programmable read only memory (eeprom) contained 0 critical errors.The potassium (k+) value indicated that the monitor has been appropriately calibrated, when calibration was last performed.The reported complaint date of when the problem occurred is (b)(6) 2025.The sample calibration, according to the eeprom, was last run on (b)(6) 2025 and (b)(6) 2025, indicating calibration was not run the day the issue occurred.Sample calibration was run and the monitor passed.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: 23397541
• Report Number: 1828100-2025-00266
• Device Sequence Number: 21335911
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)241016
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 10/03/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 03/24/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/18/2025; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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