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 Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

The fsr discovered the issue when he was at the user facility servicing the unit.He observed water to be leaking from valve five at the 90 degree elbow fitting.He replaced the elbow fitting.The unit operated to the manufacturers specifications.During laboratory analysis, the product surveillance technician (pst) observed a hole in the elbow fitting.One end of the elbow fitting was also found to be oval instead of round.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.This complaint is related to (b)(4) / medwatch #1828100-2018-00253.

Event Description

It was reported that during the use of the device for a non-clinical activity, the unit was leaking.There was no patient involvement.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7537251
• MDR Text Key: 109048197
• Report Number: 1828100-2018-00275
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

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: Other
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2007
• 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