MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO CDI 500 BLOOD PARAMETER MONITOR

Model Number 500AVHCT

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the pco2 reading on the blood parameter monitor (bpm) was drifting.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.Per clinical review on (b)(6) 2014: the bpm was gas calibrated with the 540 calibrator prior to use and the calibration passed.Acetate prime solution (plasmalyte) was used per normal practice, by the prime was buffered with sodium bicarbonate and the prime ph was >7.0.On the initiation of cpb and prior to the first in-vivo recalibration, the partial pressure of carbon dioxide (pco2) was measured on the bpm as about 80mmhg.The lab analyzer measured about 40 mmhg.After the in-vivo recalibration and a number of other re-calibrations, the paco2 measurement of the bpm varied significantly from the lab analyzer and in most cases the bpm was displaying high numbers than the lab analyzer.The other measurements (other parameters) of the bpm were tracking very closely to the lab analyzer.The perfusionist (ccp) stated that no unusual medications were used during the case.The ccp stated it was obvious the bpm was not accurate (in regards to pco2) and no pt interventions were done, due to the pco2 measures of the bpm.The cause was completed successfully, without delay and without associated blood loss.There was no harm observed or reported.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

• Brand Name: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3832583
• MDR Text Key: 16448962
• Report Number: 1828100-2014-00204
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• 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
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LAB ANALYZER