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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMP TCM II COOLING AND HEATING SYSTEM
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMP TCM II COOLING AND HEATING SYSTEM Back to Search Results
Model Number 4415
Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2014
Event Type  malfunction  
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the cooler heater unit developed a prime fault.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or adverse consequences to the patient.
 
Manufacturer Narrative
It was determined by technical support to be a faulty prime psi switch.Technical support gave the customer, in an email, the part number of the prime psi switch and the price, along with the instructions on how to change the switch.
 
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Brand Name
TERUMP 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 Key3896490
MDR Text Key4673641
Report Number1828100-2014-00443
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
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 Received05/16/2014
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? No
Date Manufacturer Received04/24/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2005
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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