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 Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

No consequences or impact to patient.Improper device output.Monitor.Evaluation is in progress, but not yet concluded.This complaint is related to (b)(4)/ medwatch #1828100-2018-00089.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was an error with the ph measurement.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2018, the clinicians calibrated the shunt sensor with both gas a and b for the procedure without concerns or errors.During the initial part of the bypass procedure, prior to the first in-vivo calibration, the ph value was reading 1.0 and the partial portion of oxygen (po2) was reading 100 mmhg.The values from the arterial blood gas (abg) are not known at this point for it was prior in-vivo calibration.The noted differences in the values were rectified after the first in-vivo calibration and the parameter values were consistently accurate the remainder of the procedure.There was no delay due to the perceived inaccuracies on the blood parameter monitoring (bpm).The team did not change the shunt sensor or the monitor during the procedure.There was no blood loss, nor harm associated with the incident.

Manufacturer Narrative

The reported complaint could not be confirmed.During laboratory analysis, the product surveillance technician (pst) was unable to verified the reported issue.The monitor was placed in its operate mode for 3 hours at ambient room temperature, arterial and venous blood parameter monitors (bpm) ph, carbon dioxide (co2), oxygen (o2), potassium (k+) and temperatures readings showed no anomalies or any erratic values and were stable.Monitor was placed in its service mode again and another bpm standard reference sensor test (srs) test on arterial and venous bpm's seven channels was performed and remained consistent with the previous testing, with service mode alert limit failures above the +20% to -30% limits set for drift.Monitor was restarted and again passed startup self-diagnostics.No accuracy is claimed before an in-vivo calibration is performed with the 1.69 software.The clinical review action item states that the clinicians acknowledged that after in-vivo calibration was performed the parameter values were consistently accurate the remainder of the procedure.The monitor operated as intended following in-vivo calibration; as per the instructions for use (ifu) states.Per central engineering, there was no claim of accuracy before in-vivo process had taken place.As a result, blood loop testing is not required.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
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7290208
• MDR Text Key: 101012109
• Report Number: 1828100-2018-00091
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

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: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1