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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO TCM II COOLING AND HEATING SYSTEM
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO TCM II COOLING AND HEATING SYSTEM Back to Search Results
Model Number 4415
Device Problem Leak/Splash (1354)
Patient Problem Not Applicable (3189)
Event Date 04/02/2014
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 at the tee fitting near valve #6.Perfusionist (ccp) noticed the leak when machine was just sitting in the pump room.There was no pt involvement.
 
Manufacturer Narrative
Technical support advised the user facility biomedical engineer (biomed) to replace the tee fitting.
 
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Brand Name
TERUMO TCM II COOLING AND HEATING SYSTEM
Type of Device
TERUMO 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 Key3943753
MDR Text Key4641218
Report Number1828100-2014-00309
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/07/2014
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 Number4415
Device Catalogue Number4415
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/07/2014
Initial Date FDA Received04/30/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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