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	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the bpm would slowly revert to reading values between two and three, while the correct values were between four and five.This was tested using manual blood gas results.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) potassium (k+) levels were reading incorrectly.The bpm was recalibrated mid case, it worked for a small period of time, before the readings were incorrect again.Manual blood gas analysis was used for the remainder of the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the blood parameter monitor (bpm) to lab use only (luo) testing equipment.The monitor was set to operate mode with a standard reference sensor (srs) and cuvette attached to the respective probes.The monitor was allowed to run in operate mode for approximately one hour.During this time several in vivo adjustments were made to the potassium (k+) value all with the correct response.The reported behavior was not present during the evaluation.
Additional Manufacturer Narrative
The reported complaint was not confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Event or Problem Description
Per clinical review on 12jul2023, the team experienced a problem with their blood parameter monitor (bpm) during cardiopulmonary bypass (cpb), described as potassium (k+) levels reading incorrectly, with no delay, no blood loss, and successful completion of the procedure.
Additional Manufacturer Narrative
The service repair technician (srt) found the arterial blood parameter monitor (bpm) probe to exceed alert limits.The arterial bpm probe was replaced as the most likely cause of the reported issue.The unit operated to the manufacturer's specifications.

• 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: 17459862
• Report Number: 1828100-2023-00214
• Device Sequence Number: 11409213
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)200707
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 12/13/2023

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: 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: 07/28/2023
• Supplement Date Received by Manufacturer: 08/25/2023; 09/28/2023; 11/21/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/15/2023; 10/20/2023; 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2020
• 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: BLOOD GAS ANALYZER
• Patient Sex: Unknown