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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT Back to Search Results
Model Number 809810
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
The issue was discovered when the user facility was cleaning the unit. Per field service representative (fsr), verified the reported complaint. The blue wires in the heater on channel a are open. Replacements parts are no longer available, therefore no parts will be replaced. The user facility opted to continue to use the unit on channel b.
 
Event Description
It was reported that during the use of the device for a non-clinical activity, the heater cooler displayed an e08 alarm. There was no patient involvement.
 
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Brand NameTERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
douglas patton
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key7483965
MDR Text Key107462607
Report Number1828100-2018-00231
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071521
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number809810
Device Catalogue Number809810
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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