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, the monitor was reading high potassium (k+) values.This has been an issue for a couple of weeks, but they have been using the monitor as is.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review on (b)(4) 2014: according to the perfusionist (ccp) they have had a couple of isolated incidents in which the potassium (k+) value of the cdi 500 did not agree with the lab analyzer.The ccp stated they do a gas calibration with the cdi 540 and they enter the k+ code that is o n the shunt sensor package label.On these couple of cases, after the in-vivo recalibrations, the k+ tends to drift away from the lab analyzed result and the ccp stated that the drift is not consistent as the cdi 500 k+ may be higher or lower than the lab analyzed result.There were no error codes displayed.The ccp also stated the unit has been working well recently and they have not seen the issue again.

Manufacturer Narrative

The disposable shunt sensors were not saved.The cases were completed successfully, without delay and without associated blood loss.There was no harm observed or reported.

• 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: 4208775
• MDR Text Key: 4964817
• Report Number: 1828100-2014-00871
• 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: 10/02/2014

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: 10/02/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2001
• 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