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 Type  malfunction  

Manufacturer Narrative

Per the user facility, in a previous case the bpm initially failed to calibrate.It was used without recent calibration and during use an f101 message displayed on the screen.It was also noted per the perfusionist that the arterial probe was hotter to the touch than normal.During laboratory analysis, the product surveillance technician (pst) observed the potassium (k+) value to fluctuate.The monitor was put in operate mode while making in vivo adjustments and the k+ value ranged from a low of 6.3 to a high of 9.8, regardless of the values set or any other variables.The monitor was powered on in service mode and the service blood parameter monitor (bpm) test was performed.The bpm probe passed all parameters of the test.A lab use only (luo) monitor was set up and allowed to operate in the same manner as the customer unit and k+ values were consistent as expected.The bpm probe from the customer unit was removed and installed in the luo unit.The fluctuation was duplicated with the customer bpm probe and the luo monitor.The luo bpm probe was removed and installed in the customer monitor and the fluctuation was not present as expected, confirming that the issue is rooted in the customer bpm probe.Additionally the bpm probe was not found to get hot during the evaluation.

Event Description

It was reported during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) potassium value was fluctuating.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: the manufacturer's clinical specialist spoke with the user facility's service associate regarding the incident the team had with the blood parameter monitor (bpm) during cardiopulmonary bypass.The date of occurrence is unknown.The team set up and calibrated the bpm without issue for the case.It was noted that the bpm was warmer (heat generated) than normal.During bypass, the potassium reading was continuously fluctuating out of what was normal.This occurred prior to an in-vivo calibration and post in-vivo calibration.All other parameters were reading as expected.The team did not exchange the bpm, they continued the surgical procedure without issue and without delay.There was no blood loss or harm due to this occurrence.

Manufacturer Narrative

The reported complaint was confirmed.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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: 11779404
• MDR Text Key: 252016380
• Report Number: 1828100-2021-00163
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190423
• 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
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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: 04/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1