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

Model Number 4415

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 01/01/2014

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed.The field service rep (fsr) found that the unit was leaking from the t-fitting and when removing the t-fitting, it broke into the solenoid valve.The fsr replaced the solenoid valve and the t-fitting and performed a release test.The unit operated to mfr specs and was returned to clinical use.If add'l info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported by the user facility's biomedical engineer (biomed), the heater cooler unit was leaking by the manifold area.No other details regarding the nature of this event were provided.

• 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 rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4099196
• MDR Text Key: 19453166
• Report Number: 1828100-2014-00700
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/08/2014

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
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• 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