MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AHCT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, there was a potassium drift.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review on (b)(6) 2016: perfusionist stated they frequently see k+ drift and / or inaccurate values during the rewarming phase of cpb.This cdi 500 monitor is the only unit at this hospital.Perfusionist stated they do gas calibrate and do enter the k+ code on the shunt sensor package, each case.Their prime solution consists of 1200 ml of plasmalyte or isolyte and they add 25 meq of sodium bicarbonate (nahco3) to the prime solution to buffer the acidity of the plasmalyte.After the calibration is completed, the shunt sensor is placed in the cpb circuit and is exposed to the prime solution prior to cpb.This exposure can be many minutes to hours.The cdi 500 is kept in standby prior to the start of cpb, so prime ph levels are not known.In review of the case printout, the k+ was adjusted to the lab analyzed value on 1st in-vivo calibration and the k+ was adjusted to 4.2 mmol / l at 11:23:55.A 2nd in-vivo is performed at 11:54:58 and the lab analyzed k+ was 4.5, but the cdi 500 measure was 6.1.After the cdi 500 was adjusted, the cdi k+ measure started to rise and over a 10 minute period rose from 4.6 to 5.6 mmol / l, even though no k+ was administered.A 3rd in-vivo calibration was performed at 12:22:40 and the cdi 500 measured k+ was 7.7 mmol / l, whereas the lab analyzed value was 5.3 mmol / l.Perfusionist was ask to consider isolating the shunt sensor from the prime solution prior to cpb and he agreed to try that technique.A follow up will be made after few days to check the results.The procedure was completed successfully, without delay and without associated blood loss.There was no harm.

Manufacturer Narrative

The reported complaint was confirmed.No part will be returned to the manufacturer for evaluation since the system is now working adequately.The user facility perfusionist tried multiple techniques to resolve the issue.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: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6212428
• MDR Text Key: 63805434
• Report Number: 1828100-2016-00827
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

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: 12/06/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-11/08/11-026-C
• Patient Sequence Number: 1