MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AVHCT

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the device was showing high values for partial pressure of carbon dioxide (pco2).Extra blood gases were drawn to determine the pco2 levels.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the blood parameter monitoring (bpm) system calibrated without issue for a cpb procedure on (b)(6) 2018.The team calibrated the bpm shut sensor with both gas a and gas b, along with placing the potassium (k+) code into the monitor.After commencing cpb, the team noticed that their pre in-vivo pco2 was reading very high.The team stored the values, and performed the in-vivo calibration with the arterial blood gas (abg) values.The team pressed the recall button, placed all the values into the re-calibration screen and pressed the soft check key to resume to the operate mode.Once resuming to the operate mode, the unit gave a sensor intensity error on the arterial pco2 value.Since they were in the middle of a procedure, the team opted to keep the unit and shunt sensor and proceed with taking intermittent blood gases to supplement the parameter information that was available.It was suggested to the perfusionist, since they do not isolate their shunt sensor from their prime, and they do carbon dioxide (co2) flush their circuit, and do not know the ph of the priming solution, that they isolate the shunt sensor and open it to the blood path after the initiation of cpb.The incident did not delay the continuation of the surgical procedure.There was no blood loss or harm associated with the event.

Manufacturer Narrative

The reported complaint is not verifiable.Per the user facility's perfusionist, they have isolated the carbon dioxide (co2) flushing from the center and resolving the issue.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 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7881630
• MDR Text Key: 120709786
• Report Number: 1828100-2018-00481
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• 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: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1