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

Model Number	550AVHCT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the values from the blood parameter monitor (bpm) seemed to wander and fluctuate and did not seem to be correct.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review, during a cpb procedure sometime before (b)(6) 2019, the perfusion team was concerned that their partial pressure of carbon dioxide (pco2) value was out of range and inaccurate.The team runs the prime through their shunt sensor prior to going on bypass without knowing what the potential hydrogen (ph) of their prime solution is.Secondarily, the team does not calibrate the shunt sensors with the calibrator and calibration gases.The discussion occurred regarding the difference between previous calibration and factor defaults, the need for calibration, and the need to isolate the shunt from the prime solution if the ph of the solution was unknown.During this procedure the team did not exchange the unit for another bpm.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss associated with the occurrence.
Additional Manufacturer Narrative
Please disregard the previous submission.Additional information was obtained that the values were not wandering or inaccurate but rather it was a sensor intensity error message with the arterial blood parameter monitor (bpm).

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 550
• Common Device Name: CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8984877
• Report Number: 1828100-2019-00486
• Device Sequence Number: 3323820
• Product Code: DRY
• UDI-Device Identifier: 00886799001783
• UDI-Public: (01)00886799001783(11)181207
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: 550AVHCT
• Device Catalogue Number: 550AVHCT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1