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 500AHCT

Device Problem Invalid Sensing (2293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.Per the perfusionist, co2 flush was originally at 2 liters per minute (lpm), but then decreased to 1.5 lpm during the case due to high co2 readings on the abgs (cpb suckers were decreased to limit co2 uptake).Co2 was on at 2lpm approximately 20 minutes before the first off gas was drawn.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial blood gas (abg) values were not matching.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during a minimally invasive bypass procedure in which the perfusionist was flooding the field with carbon dioxide (co2), the blood parameter monitor (bpm) did not trend the partial pressure of carbon dioxide (pco2) and ph values as closely as the perfusionist expected.On (b)(6) 2018, the perfusionist set up and calibrated the bpm shunt sensor correctly with gas a and gas b, along with placing the potassium (k+) code in the bpm.She did her first in-vivo recalibration without problem.About an hour into the procedure, after her second in-vivo her abg value had trending that concerned her.The ph on the abg was 7.31 vs.7.39 on the bpm, and the pco2 on the abg was 57 mmhg, and the bpm was 49 mmhg.The team does not expose their shunt sensor until 50 milliequivalent (meq) of sodium bicarbonate is added to the plasmalyte - a solution.I spoke with her about isolating the sensor completely from the circuit until initiation of bypass, to preserve the chemistries in the sensor.The change in temperature from in-vivo 1 and in-vivo 2 was from 34.2 degrees celsius to 28.4 celsius.The team uses co2 to flush the field for exposure and for air handling.They closely monitor their pco2 values to adjust their co2 to the field and their sweep values on their blender.After noticing the delta between the two, they just monitored the difference with additional abgs.She continued the procedure with the same shunt sensor and monitor.The incident did not delay the continuation of the surgical procedure.There was no blood loss nor harm associated with the event.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the monitor to pass startup self-diagnostics with no errors.

Manufacturer Narrative

Correction/removal number: 1828100-08/09/2010-004-c-500.The reported complaint could not be confirmed.Per central engineering the unit operated to the manufacturer's specifications.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: 7371109
• MDR Text Key: 103693344
• Report Number: 1828100-2018-00154
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Other Device ID Number: GTIN: (01)00886799001622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-08/09/2010-004-C
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER