MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP TERUMO TCM II COOLING AND HEATING SYSTEM

Model Number 4415

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, there was evidence of leakage on both sides of white tee "t" near bottom of the cooler heater unit.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.This complaint is related to mdr #1828100-2014-00092.

• Brand Name: TERUMO TCM II COOLING AND HEATING SYSTEM
• Type of Device: TCM II COOLING AND HEATING SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3896496
• MDR Text Key: 4674085
• Report Number: 1828100-2014-00369
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• 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?: Yes
• Date Returned to Manufacturer: 03/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2003
• 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