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

Model Number 500AHCT

Device Problems Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) saturated venous oxygen (svo2) were low on the blood parameter monitor (bpm).An in-vivo calibration was performed and took about 15 minutes to come up to correct values.The device was not changed out, the customer continued using the monitor and was checking other patient indicators.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on 02/17/2015: this issue was observed by the ccp, after the 1.69 software upgrade had been performed on the bpm units.Tech support spoke to the ccp after his observations.A bpm that had received the 1.69 upgrade was swapped into use during the procedure as the originally used unit (in this procedure) was having the new software (1.69) installed.The new unit did pass the color chip test (at start-up) but the ccp noticed that the svo2 measure was low (as compared to the lab analyzer) and it took 15 minutes to come back to expected and measured lab vales.The ccp also noticed issues with gas calibration (call service message) and when the potassium (k+) code was asked to be entered, the ccp claims the numeric could be entered, but not the following letter.After later discussion, it was found there may have been an issue with the calibrator as a "cf08" error code was posted.These observations occurred after the 1.69 software upgrade.Though, the svo2 was slow to agree with the lab analyzed value, the unit was used to complete the procedure and additional lab analysed values were performed to help manage the patient.The case was completed successfully, without delay and there was no associated blood loss.There was no harm observed.

Manufacturer Narrative

The reported complaint was confirmed.No product was returned to the manufacturer for evaluation.The perfusionist (ccp) stated the issue has sorted itself out.He mentioned that no gas calibration was performed and per the instructions for use (ifu) accuracy is not claimed in this situation.As the customer is aware of the new updates for the 1.69 software and has the addendum no customer letter is required.No additional action will be taken at this time.

• 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: 4563866
• MDR Text Key: 15909334
• Report Number: 1828100-2015-00142
• 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: 08/13/2015

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?: No
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 02/27/2015
• Supplement Dates Manufacturer Received: 07/24/2015; 07/24/2015
• Supplement Dates FDA Received: 05/07/2015; 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1