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

Model Number 4415

Device Problems Collapse (1099); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

It was reported that cardioplegia flow was not working in speed 3 from large to small tank on the cooler heater unit.No other details regarding the nature of this event were provided.

Manufacturer Narrative

When the fsr went out for repair he found that the hose was collapsing in thigh speed.

• Brand Name: TERUMO TCM II COOLING AND HEATING SYSTEM
• Type of Device: TCM II COOLING AND HEATING SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3832578
• MDR Text Key: 15811578
• Report Number: 1828100-2014-00203
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2002
• 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