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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) potassium (k+) value kept getting higher, even with calibrations and eventually was reading dashes.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Per clinical review: the manufacturer's clinical specialist spoke with the team at the user facility regarding the incidents the team was having with the blood parameter monitor (bpm) during a cardiopulmonary bypass (cpb) procedure.The team was having an issue with the potassium sensor during the procedure on (b)(6) 2021.The potassium readings kept getting higher and higher even with repeated in-vivo calibrations.Eventually, dashes were evident, even though the potassium was in the 5 or 6 range.The manufacturer's clinical specialist initially asked the perfusion team to use a different shunt sensor, but then decided to evaluate what their ph and their priming solution was on the circuit.They did say they use a lot of sodium bicarbonate in their prime and did expose the shunt sensor to that prime, which would cause a potassium sensor burn out and inaccuracies.The monitor was not exchanged out, and they troubleshot this issue.The team now isolates their shunt sensor from the prime and no other concerns have occurred.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss.

• 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: 12315852
• MDR Text Key: 266404856
• Report Number: 1828100-2021-00281
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)210609
• 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
• Report Date: 09/08/2021

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: 07/21/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/31/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1