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	12/20/2024
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) had incorrect and inconsistent carbon dioxide (co2) readings.There was a 20-minute delay to attain correct co2 data.As mitigation, a blood gas analyzer was used throughout the case.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: d9 evaluation is in progress, but not yet concluded.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.During laboratory analysis, the product surveillance technician (pst) connected the blood parameter monitor (bpm) to lab use only (luo) testing equipment.The monitor was booted up to operate mode and there were no failures or errors codes observed.There was no error codes indicated in the erasable electronically programmable read only memory (eeprom).The probe was attached to a 3/8-inch cuvette which had a strip of red tape to provide a static background intended to stimulate a stable operating environment.The monitor was successfully calibrated, and the hematocrit saturation (h/sat) values were set to the following sample values using the monitor's store/recall function.(saturation of oxygen (so2) 75%, hematocrit (hst) 35% and hemoglobin (hgb) 10 grams (g)/deciliter (dl)) the system was left in that state for several hours and there was no drifting, no abnormalities or anything out of the ordinary with any of the displayed values.The service repair technician (srt) could not duplicate the reported complaint.The srt powered the monitor on, and it passed self-testing.The h/sat passed service mode testing, and the arterial bpm passed in service mode testing.The arterial bpm passed intensity testing.The eeprom contained 0 critical errors.The monitor passed all testing.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: 21154090
• Report Number: 1828100-2025-00011
• Device Sequence Number: 9097862
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)220318
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/23/2025

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: 12/27/2024
• Supplement Date Received by Manufacturer: 01/21/2025; 05/01/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/11/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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