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 Problem No Consequences Or Impact To Patient (2199)

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) displayed a higher than expected pre-in-vivo.As a mitigation an in-vivo calibration was performed.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 perfusionist about the concern he had with the blood parameter monitor (bpm) svo2 readings on the new bpm versus what he was used to seeing on the old bpm svo2 pre-in-vivo.During three previous procedures before the informed date of february 3, 2020, the team stated that the svo2 values were reading different compared to the old bpm and were on the higher side.The clinical specialist conferred with the software team of the difference in expected pre-in-vivo values from the two devices and discussed this with the perfusionist.The perfusionist was informed that the expected/listed accuracy values are post the first in-vivo and all decisions should be made with confirmation from a blood gas analyzer.He stated post in-vivo the values followed as expected.There was no blood loss on these procedures.There was no harm or delay in the continuation of the surgical procedures.The question from the user was a usability/clinical question that was appropriately answered.

Manufacturer Narrative

The reported complaint was confirmed.The issue was observed prior to an in-vivo calibration.After the user calibrated, post in-vivo, the values were accurate and the unit operated as intended.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: 9769037
• MDR Text Key: 199877247
• Report Number: 1828100-2020-00092
• Device Sequence Number: 1
• Product Code: DRY
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2020

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: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 03/12/2020; 04/07/2020
• Supplement Dates FDA Received: 04/02/2020; 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1