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

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2018

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Evaluation is in progress but not yet concluded.

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.

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
• Type of Device: 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
• MDR Text Key: 134591906
• Report Number: 1828100-2019-00027
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)041210
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 01/10/2019; 03/08/2019; 04/12/2019
• Supplement Dates FDA Received: 02/04/2019; 04/02/2019; 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER