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 05/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.Customer noticed a change in the temp 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 accuracy of temperature reading couldn't be trusted.Previous to software upgrade, the arterial temperature on blood parameter monitor (bpm) was approximately one degree higher than the perfusion system oxygenator outlet temperature reading.The customer always rewarmed their patient based upon bpm reading to keep arterial temperature below 37 degrees celsius and have a known element of safety.Now the bpm unit reads approximately one degree lower than the perfusion system temperature reading, meaning we cannot trust which temperature is now accurate.Per the clinical summary on (b)(6) 2015: the australian subsidiary has reported that one of their customers (b)(6) hospital has noticed a number of issues since software version 1.69 has been installed in their units.One observation is the shunt sensor temperature is measuring lower (compared to oxygenator outlet) than in previous software.Previously, the bpm shunt sensor temperature measure was higher than the oxygenator.This issue has been reported by some other centers that have had the 1.69 upgrade.The instructions for use (ifu) is quite clear on the temperature difference between the oxygenator outlet and the shunt sensor, as the shunt is a distance away and the operating room (o/r) is quite cool.In addition, due to small shunt tubing, there is a loss of temperature as the shunt is downstream from the oxygenator.The algorithm is changed for temperature and the accuracy is tighter with the new software.Their observations, regarding temperature, do not indicate a malfunction of the shunt but is a result of improved accuracy for temperature.Manufacturer's global marketing has spoken to the australia subsidiary who will work with the customer to better explain the difference in the how the unit behaves with the new software.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: 5001211
• MDR Text Key: 24558828
• Report Number: 1828100-2015-00706
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 12/02/2005
• 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