MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550; CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS

Model Number 550AHCT

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the venous oxygen saturation (svo2) level was abnormal.It was showing at 100% which is not expected.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per the manufacturer's product engineer, the monitor was sent for blood loop testing.During testing the engineers were not able to duplicate any errors, discrepancies or problems with the monitor during testing.

Event Description

Clinical review: the team had set up the monitor for a cardiopulmonary bypass procedure on (b)(6) 2020 without issue.The monitors hematorcrit saturation (h/sat) had passed its color chip without any error messages.At initiation of bypass, pre in-vivo and post in-vivo calibration, venous saturation was at 100%, whereas the patient values were well below that number.The team used a 1/2 inch cuvette in the venous line, and there were no preset offsets in the system at this time.The team continued use of the device, and just supplemented the venous saturation values with blood gas testing.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician observed the so2 on-screen value was 100% when the color of the sample gradient was brighter.Values could be adjusted using an in-vivo recalibration after approximately 25 minutes.When the sample gradient was darker, adjustments were easier to make.

Manufacturer Narrative

The reported complaint was confirmed.Service repair technician (srt) could not duplicate the reported complaint.The hematocrit saturation (h/sat) module passed service mode testing.The h/sat module was replaced as a precaution.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 550
• Type of Device: CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 10286134
• MDR Text Key: 200047704
• Report Number: 1828100-2020-00268
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190424
• Combination Product (y/n): N
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER.