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

Model Number 500AHCT

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the saturated venous oxygen (svo2) reading was not accurate on the blood parameter monitor (bpm).This issue has occurred since the recent notice of field correction (nfc) upgrade.The device was not changed out, as they recalibrated the unit and continued to use.The surgical procedure was completed successfully.There was no delay, no blood loss, nor advance consequences to the patient.

Manufacturer Narrative

Per the clinical review on (b)(4) 2015: since this bpm unit was upgraded to 1.69 version software, the svo2 measure is much lower than expected and much lower than measured by a laboratory analyzer.The svo2 measure of the bpm is 15-20% points lower than the laboratory analyzer prior and at the first in-vivo calibration.The lower than expected svo2 is detected by the user, as the color of the venous blood in the cpb circuit does not represent this low measure.After the in-vivo calibration is performed, the bpm svo2 measure is closer to the laboratory analyzed value for the remainder of the procedure and is usually within +/- 5% units of the laboratory analyzer.Since the upgrade, the other measured parameters of both the hematocrit saturation module (h/sat) probe and the bpm shunt sensor have been in agreement with the laboratory analyzer.The cases have been completed successfully, without delay and without associated blood loss.There has been no harm observed.

Manufacturer Narrative

During the laboratory evaluation, the product surveillance technician (pst) was unable to duplicate the reported issue since the pst could not duplicate customer¿s clinical setting.The monitor was sent to central engineering for further evaluation.

Manufacturer Narrative

The reported complaint was confirmed.This occurred after the 1.69 software update, which the addendum created for the update claims no accuracy unless both a gas calibration and in-vivo calibration are performed.No blood loop testing was determined necessary as the issue was due to pre in-vivo inaccuracies only.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: 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: 4777956
• MDR Text Key: 5799465
• Report Number: 1828100-2015-00403
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/29/2016; 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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