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

Model Number 500AHCT

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, one of the parameters was about forty off.The device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.Per clinical review on (b)(6) 2014: the issue the perfusionist (ccp) experienced is that the blood pressure monitor (bpm) hematocrit and hemoglobin measures are reading much higher than the lab analyzed sample.The ccp mentioned that in the most recent procedure, after the initiation of cardiopulmonary bypass (cpb), the bpm hematocrit value was displayed as 28% and when the first in-vivo calibration was performed with the lab analyzer, the actual hematocrit was 18%.After the in-vivo re-calibration was completed, the ccp stated the hematocrit values were closer, but still drifting higher than the lab analyzer by 6-8% points.This drifting continued after each procedure.The ccp stated he could not trust the bpm data and he conducted more frequent lab analysis than usually needed.There were no issues during start-up and the unit passed the color-chip test.The ccp saw no issues with the adequacy of the hematocrit saturation module (h/sat) coupling to the cuvette.

• Brand Name: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4180568
• MDR Text Key: 19721278
• Report Number: 1828100-2014-00845
• 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: 09/23/2014

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/15/2014
• 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