MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number	500AHCT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the carbon dioxide (co2) value did not match with the manual laboratory values, there was a significant increase and decrease.As a result, the sweep gases were increased.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the perfusionist was corresponded with regarding the incident on (b)(6) 2020 with their blood parameter monitor (bpm).The team stated that the first in-vivo after going on cpb had no problems.The second in-vivo had no problems and no real discrepancies.After third in-vivo, elevated partial pressure of carbon dioxide (pco2) was observed on the bpm 45 mmhg.Clinical adjustments were made and the bpm continued to be in the lower 50's mmhg.Another in-vivo calibration was done 30 minutes later and arterial blood gas (abg) was reading pco2 in the lower 30's while the bpm was reading in the mid 50's mmhg.The team stated that the they did not gas calibrate their shunt sensors prior to cpb.The team was not aware of the sodium and ph restrictions on their priming solutions.The clinical specialist informed the perfusionist of the information in the instructions for use (ifu) regarding isolation of the shunts sensor if the ph and the sodium in their prime was out of the range listed.The clinical specialist also informed the team that the accuracy of the bpm gas values would only be accurate if the system was gas calibrated prior to use on a patient.The unit was not exchanged out.There was no harm or blood loss associated with the event.There was no delay in the continuation of the surgical procedure.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician observed the monitors intensity values of carbon dioxide (co2) for an hour and there were no significant changes.The blood parameter monitor (bpm) cable was flexed and the probe agitated but no significant changes in the co2 intensity were noted.
Additional Manufacturer Narrative
The reported complaint was confirmed through information obtained by the clinical specialist.The service repair technician was unable to duplicate the reported complaint.He observed no significant changes in the carbon dioxide intensity values throughout the evaluation.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 500
• Common Device Name: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 9717766
• Report Number: 1828100-2020-00062
• Device Sequence Number: 361790
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)100922
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2020

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/17/2020; 05/29/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/06/2020; 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD GAS ANALYZER