MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING

Model Number 4415

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

The device was brought to the biomedical technician (bmet) shop for repair.The bmet recalibrated the device and it resolved the issue.The unit is now working fine with no further issues identified.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the heater cooler was resetting when starting up.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.Through collaboration with tech support and the user facility's biomedical technician (bmet) it was found that the a/d timer board calibration was out of specification.The bmet recalibrated the device and it resolved the issue.The unit is now working fine with no further issues identified.No unit will be returned and the unit is at its end of life.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: SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8728214
• MDR Text Key: 148991716
• Report Number: 1828100-2019-00337
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

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: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1