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 Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the device for a cardiopulmonary bypass (cpb) procedure, the first on-pump carbon dioxide (co2) was reading 100 mmhg, which did not match the independent blood gas that was drawn.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the unit was calibrated for a procedure by the perfusionist, without issue.The perfusionist on that procedure noted that the partial pressure of carbon dioxide (pco2) prior to the first in-vivo calibration was reading 100 mmhg.He took an arterial blood gas and re-calibrated the unit without issue, and the pco2 adjusted and was within specifications the remainder of the procedure.It was reiterated to the team that the gases are not within accuracy specifications until after the first in-vivo calibration.This incident did not delay the continuation of the surgical procedure.There was no harm or blood loss associated with the incident.
Additional Manufacturer Narrative
Evaluation is in progress but not yet concluded.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) observed no carbon dioxide (co2) issues while performing sample functions.All values were able to be adjusted and the blood parameter module (bpm) passed standard reference sensor (srs) testing.The bpm has been potted.There were no error codes recorded on the day of the complaint.
Additional Manufacturer Narrative
The reported complaint was confirmed.Per the service repair technician (srt), the monitor passed all testing and the unit operated to the manufacturer's specifications.No accuracy is claimed before an in-vivo calibration is performed with the 1.69 software.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: 8254910
• Report Number: 1828100-2019-00027
• Device Sequence Number: 1911849
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)041210
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 04/15/2019

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: 01/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 03/08/2019; 04/12/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/04/2019; 04/02/2019; 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1828100-08/07/15-002-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD GAS ANALYZER