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 04/17/2015

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 temperature on the blood parameter monitor (bpm) display was 1 - 1.5 degrees celsius (c) lower than what the in-line temperature probes were showing.The device was not changed out, as they continued to use the unit 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: the perfusionist (ccp) has noticed that since the 1.69 software upgrade, the shunt sensor temperature measurement differential between the oxygenator arterial outlet and the shunt sensor is larger (than 1.65 version).With the previous 1.65 version of software, the difference in measured temperature between the oxygenator outlet temperature and the shunt sensor was about 0.5 - 1.0 degree celsius.With version 1.69, the temperature difference consistently approaches 1.5 degrees celsius.The ccp stated that he understands there will be a difference in the blood temperature between the two sites (due to travel time, flow rate, tubing diameter of the shunt line, and the ambient temperature of the room), but he has reported the issue due to their observations of differences between the two software versions.The ccp stated that they use the oxygenator outlet temperature as a guide in adjusting the heater cooler water temperature to guide the management and degree of rewarming and cooling of the patient.The ccp stated they use the bpm shunt sensor as a secondary guide of arterial blood temperature, as the temperature is continuously displayed and within good view on the bpm large display.The ccp's concern is the risk of overwarming the patient is elevated, if the user is not aware of the temperature difference between the shunt and the oxygenator.Clinical services reviewed with the ccp, that the accuracy of the temperature measurement at the shunt has been improved and he now understands why they are observing a larger differential between the two sites.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: 5000619
• MDR Text Key: 24558638
• Report Number: 1828100-2015-00699
• 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: 08/08/2002
• 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