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

Model Number	550AVHCT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's subsidiary's clinical specialist, the deviation was not found in any of the measured parameters, only the calculated be value.He found that the calculation formula of the bpm was different than that of the bga.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the base excess (be) values on the blood parameter monitor (bpm) were deviating from the values gathered by the blood gas analyzer (bga).As mitigation, the values from the bga were used.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: the user reported an issue with their blood parameter monitor (bpm) during cardiopulmonary bypass (cpb).Specifically, the user observed a deviation of the base excess value when compared to the values obtained from the lab.It is unclear if this deviation is a positive or negative deviation from the lab blood gas values.There was no delay to the procedure.The unit was not changed out, and the surgery was completed successfully.There was no blood loss or adverse events reported.The user confirmed base excess (be) values from an abl 90 flex blood gas analyzer.
Additional Manufacturer Narrative
The reported complaint was not verifiable since the product was not returned for evaluation or testing.Multiple diligence attempts for part return were unsuccessful.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: 17003057
• Report Number: 1828100-2023-00151
• Device Sequence Number: 20614589
• Product Code: DRY
• UDI-Device Identifier: 00886799001783
• UDI-Public: (01)00886799001783(11)201024
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/11/2023

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: 550AVHCT
• Device Catalogue Number: 550AVHCT
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 07/21/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/20/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2020
• 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: ABL 90 FLEX BLOOD GAS ANALYZER
• Patient Sex: Unknown