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 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 summary on (b)(6) 2015: per the email sent to the perfusionist (ccp), the new bpm software upgrade (1.69) has improved accuracy for temperature measurement as compared to software version 1.65.During blood lab testing comparing 1.65 to the new 1.69 version of software, precision thermistors were placed in the shunt line circuit and they were compared to the temperature being measured in the shunt.The accuracy of the bpm temperature compared to in-line thermistors was: + / - 0.878 degrees c for software version 1.65.+ / - 0.212 degrees c for new software version 1.69.The accuracy is improved in the new software and this information was detailed in manufacturer clinical services email to the customer.This is why they have observed a difference in the bpm temperature as compared to the measured oxygenator blood outlet temperature.There is no indication of a device malfunction, and this was simply an observation of a difference in the bpm shunt temperature as compared to the oxygenator outlet temperature.The bpm unit was used for the procedure and the case was completed successfully without delay and without associated blood loss.There was 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: 5002687
• MDR Text Key: 24557952
• Report Number: 1828100-2015-00698
• 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
• 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