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 Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.Customer noticed a change in the temperature readings on the bpm after the 1.69 software upgrade.They were notified that this is due to the temperature algorithm design change in the upgrade to make it more accurate and the difference is expected.The 1.69 software upgrade supplement sent out does not specify there would be a change in the temperature algorithm, it only states the accuracy limits have been revised.No product will be returned for further evaluation.No additional action will be taken at this time.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the perfusionist (ccp) was seeing a difference of two degrees celsius (c) from blood parameter monitor (bpm) versus the patient temperature.The device was not changed out, as they continued to use for the case.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: per the manufacturer sales representative (sr), the reported issue is that the temperature measure of the bpm shunt sensor is about two degrees c different than the arterial blood temperature.Clinical services made the point to the sr and he has spoken to the perfusion team that the measured temperature in the shunt sensor will routinely be different than the temperature measurement at the oxygenator outlet.This is due to the distance between the oxygenator outlet and the shunt sensor.This concept is actually detailed in the instructions for use (ifu) in the troubleshooting section (section 9) with a note: "a shunt line will normally be different in temperature from the main arterial line temperature.Smaller diameter tubing and slower flow will increase the difference by allowing room temperature to affect the blood in the shunt line".After further conversation, it was discovered this behavior coincides with the 1.69 software upgrade and this behavior has been seen with all of their bpm units.The 1.69 software upgrade did have an update related to the temperature measurement algorithm.After further review, the perfusion team feels this is purely an observation and slight difference in temperature variation due to the software change.After discussion, they do not feel that a malfunction has occured.They continue to use their bpm units for all of their clinical cases.The cases have been completed successfully, without delay and without associated blood loss.There has been no harm observed.

• 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: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5001167
• MDR Text Key: 24558935
• Report Number: 1828100-2015-00705
• 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 faci
• Reporter Occupation: Other
• Remedial Action: Recall
• 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: Not provided
• Initial Date FDA Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• 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