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 Problems Display or Visual Feedback Problem (1184); Smoking (1585)

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

Event Type  malfunction  

Event Description

It was reported that the blood parameter monitor (bpm) display went blank and started to smell like smoke.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was an approximated few minutes of delay, no blood loss, nor adverse consequences to the patient.

Event Description

It was reported that the alleged event occurred during use of the device for cardiopulmonary bypass.

Manufacturer Narrative

The reported complaint was not verifiable.No analysis was performed since the unit cannot be serviced by the manufacturer at it is end of service life and was not returned for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion a supplemental report will be filed accordingly.

Event Description

Per clinical review: on (or before) 18jan2022, the team experienced a problem with their blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb), whereby the screen went blank and the unit started smelling of smoke.It was changed out, with a slight delay, no blood loss, and the procedure was completed successfully.The manufacturer's clinical specialist attempted to contact the user facility to clarify details, such as the actual date of the occurrence, but did not hear back.The 18jan2022 is the date the manufacturer was informed.According to the report, the device was manufactured on 15jul2003, so it was not returned for evaluation, and a new bpm was ordered for replacement.

• 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: 13290706
• MDR Text Key: 284029084
• Report Number: 1828100-2022-00027
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2003
• 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