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 06/16/2015

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 (cpb) procedure, the arterial temperature reading was half degree lower on the blood parameter monitor (bpm) than anticipated.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 summary on (b)(6) 2015: since the software upgrade of the bpm from version 1.65 to 1.69, this perfusionist (ccp) has observed that the shunt sensor temperature measurement is measuring lower than previously observed with software version 1.65.According to the ccp, the bpm shunt sensor temperature was usually about one degree celsius less than the oxygenator outlet (arterial blood) temperature, but since the software upgrade the shunt sensor temperature is about 1.5 degree celsius lower than the oxygenator outlet.This did not impact the procedure nor change management of cpb in anyway.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.The instructions for use (ifu) does address an expected difference between the shunt sensor temperature and the oxygenator outlet temperature.The temperature at the shunt differs from the arterial outlet as the shunt is a distance away from the oxygenator outlet and the shunt is connected to small diameter tubes in the cpb circuit which results in cooling of the blood.The temperature accuracy of the shunt sensor has been improved in software version 1.69 and is part of the improved accuracy claims in shunt sensor performance.The measured temperature (post 1.69) is actually a more accurate temperature than in version 1.65, but the difference has been observed by a number of users since 1.69 has been completed.The new temperature algorithm was not included in the ifu supplement that was given to users after the upgrade was completed.

• 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: 5001637
• MDR Text Key: 24553547
• Report Number: 1828100-2015-00709
• 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: 10/14/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1