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, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) was giving an inaccurate partial pressure of carbon dioxide (pco2) reading.As a result, blood gases were manually checked about every 15 minutes until the case was done.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 contacted regarding the incident the team had with the bpm during a cpb procedure on (b)(6) 2020.The team stated that the pco2 was drifting from the blood gas analyzer approximately 20 mmhg during the entirety of the procedure.She stated that they recalibrated the pco2 several times, and it would drift away from the actual trending within 30 minutes repeatedly, and that it was significant enough that it influenced them to take blood gases about every 15 minutes.The team did not gas calibrate the shunt sensor prior to using it on the procedure.It is not their practice to gas calibrate, and the team was informed of the need for gas calibration for the accuracy of the gas values.There was no harm or blood loss due to this event.This did not cause a delay in the continuation of the surgical procedure.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) could not verify the reported complaint.The monitor was turned on and set up for calibration per instructions for use.Gas bottles were installed with the a bottle on the left and the b bottle on the right.The shunt sensor was secured to the blood parameter monitor (bpm), ensuring the sensor is clipped in on both sides.The small blue cap was removed from the sensor, and the large blue cap was loosened.The bpm with sensor attached was fully inserted into the calibrator.The potassium (k+) code from the shunt sensor package was entered in the calibration screen.The sample calibration was successful.The pst put the monitor into operate mode and an in-vivo adjustment was performed to set the partial pressure of carbon dioxide (pco2) value.With the shunt sensor, the value decreased to 25 within two hours.In vivo adjustment can be used to set the value back to 40.Using a standard reference sensor (srs), the value remained steady for several hours after being set to 40.After 4 hours, the on-screen pco2 value was 39.The bpm did not significantly shift while operating.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) could not duplicate the reported complaint.The monitor passed self-testing, as well as the blood parameter monitor (bpm) intensity testing.There were no errors or irregular values that occurred.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
• 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 48104
• MDR Report Key: 10102986
• MDR Text Key: 201560270
• Report Number: 1828100-2020-00204
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)020313
• 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
• Report Date: 10/22/2020

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 06/10/2020; 09/29/2020
• Supplement Dates FDA Received: 06/30/2020; 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER