MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AHCT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

During laboratory evaluation, the product surveillance technician (pst) observed the unit to display a temperature significantly lower than the actual temperature.He first observed the monitor to measure the air temperature within 0.4 celsius (c) of the actual temperature, and when connected to a shunt sensor, was within 0.7c.He then placed the unit in a 15c environment where the measured temperature dropped quicker than expected but then stabilized.Then the unit was warmed to 30c where the measured temperature dropped from 18.6c to 9.6c.It was determined the measured temperature readings were fluctuating and read low relative to actual temperature.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) was reading a lower temperature than expected.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• 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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 12804534
• MDR Text Key: 281530118
• Report Number: 1828100-2021-00422
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1