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 04/22/2015

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 continued to use.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2015: this behavior was observed after the bpm unit had been upgraded from version 1.65 to 1.69.The unit passed the color chip test at monitor start-up.In the first minutes of cpb, the svo2 was significantly lower than what they usually saw with version 1.65.The svo2 was being measured between 50-60%, even though the blood color in the venous line appeared brighter than this measured level.When an in-vivo calibration was performed 10-15 minutes into pcb, it was observed the svo2 measure of the bpm was 10-20% points lower than the laboratory analyzer.After the svo2 of the bpm was adjusted to the laboratory analyzed value, the bpm was closer the remainder of the procedure, usually less than or equal to 5% points of the laboratory analyzed value.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

This complaint is related to mdr #1828100-2015-00397 and mdr #1828100-2015-00398.

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.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: 4777958
• MDR Text Key: 5779694
• Report Number: 1828100-2015-00399
• 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
• Report Date: 11/30/2015

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: 04/22/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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