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

Model Number 4415

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a non-clinical activity, the cooler heater unit was leaking.The issue was found when unit was turned on in the storage room.There was no pt involvement.

Manufacturer Narrative

The field service rep (fsr) verified the water leak on the cooler heater unit.The fsr observed a leak from a connector coming out of the cardioplegia pump.The fsr resealed both connector ends with teflon tape.The fsr observed a second leak at the t-connector coming out of valve 4.The fsr disassembled the valve and resealed the t-connector with teflon tape.The fsr performed a test release with no failures noted.The unit operated to mfr specifications and was returned to clinical use.If additional info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO TCM II COOLING AND HEATING SYS
• Type of Device: TCM II COOLING AND HEATING SYS
• 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: 4058612
• MDR Text Key: 4811054
• Report Number: 1828100-2014-00690
• 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: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• 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
• Date Manufacturer Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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