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 Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2018

Event Type  malfunction  

Event Description

The manufacturer's technical support specialist reported that during preventive maintenance (pm) of the device, the mechanical stop in the over temp was not working.There was no patient involvement.

Manufacturer Narrative

The manufacturer's technical support specialist replaced the thermostat resolving the issue of the heater cooler heating past 43 degrees.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the thermostat did not close at 43 degrees celsius (c) as designed.During testing the thermostat did not close until 50 degrees c.There was not any kind of mechanical stop on the thermostat.If additional information 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: 7992360
• MDR Text Key: 125779120
• Report Number: 1828100-2018-00554
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1