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 500AVHCT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

This complaint is related to (b)(4) / medwatch #1828100-2020-00099.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the unit took time for the partial pressure of carbon dioxide (paco2) value change to be reflected.There was no problem found on the paco2 rising after the circulation was stopped.After the circulation was restarted, the displayed value of the paco2 did not go down as was being shown on the blood gas test.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the manufacturer's clinical specialist spoke with the team regarding the incident with their blood parameter monitor (bpm) during a cpb procedure on (b)(6) 2019 and (b)(6) 2019.The complaint states that it takes time for the bpm paco2 value change to be reflective on the device.The device was gas calibrated without issue.It is not known if this occurrence was before or after the first in-vivo calibration of the pco2.It is not known what the values on the bpm were versus the values from the blood gas analyzer.Additionally unknown information on these two cases are the ph of the prime solution, and the sodium values, both which may cause issues with the chemistries.There was no delay in these surgical procedures.The unit was not exchanged out.There was no blood loss, harm or delay in the continuation of the surgical procedures during these occurrences.

Manufacturer Narrative

Updated blocks: d10, h3 and h6.During laboratory analysis, the product surveillance technician observed the monitor to respond to changes in the state of the shunt sensor at an appropriate speed.There was no delay in the update of the values.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) was unable to duplicate the reported issue.The monitor passed all applicable testing and 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
• 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: 9777356
• MDR Text Key: 201427353
• Report Number: 1828100-2020-00101
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K123039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

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
• Device Operator: Health Professional
• Device Model Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/04/2020; 08/07/2020
• Supplement Dates FDA Received: 03/27/2020; 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER.