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

Model Number 500AVHCT

Device Problem High Test Results (2457)

Patient Problem Blood Loss (2597)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a veno-venous (v-v) procedure, the venous hematocrit saturation module (h/sat) reading was 100 on the blood parameter monitor (bpm).The device was not changed out, as they continued to use the bpm.This is an extracorporeal membrane oxygenation (ecmo) venous oxygen (o2) problem.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical summary on (b)(6) 2015: it was used for h/sat measurements and there was a shunt sensor in the venous line.The shunt sensor was gas calibrated and it appears the h/sat probe passed the color chip test.There was an error message posted for a period of time, but the users could not recall or did not notice.During ecmo, the saturated venous oxygen (svo2) measurement (h/sat) was displayed as 100%.The svo2 is generally in the range of 60-80%.An svo2 of 100% is an arterial like measurement.The users observed the venous and arterial blood and the venous blood was darker in color and this indicated that 100% measurement was not accurate.The venous shunt sensor (bpm) partial pressure of oxygen (po2) was used to calculate the svo2.The inaccuracy did not lead to transfusion and/or did not lead to any other mistreatment of the patient.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The software version of the unit is 1.65 per the user facility's biomedical engineer.(biomed).

• 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: 4563897
• MDR Text Key: 5459767
• Report Number: 1828100-2015-00117
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/09/2010-004-C
• Patient Sequence Number: 1
• Patient Weight: 3