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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 Insufficient Heating (1287)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2018
Event Type  malfunction  
Event Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the heater-cooler displayed an "e08" error message on channel a. As a result, an alternate device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Per clinical review: the team had an e08 channel on the patient side of their heater cooler during a cpb procedure on (b)(6) 2018. The heater cooler was unable to warm up the heat exchanger, and consequently the patient, therefore the perfusionist exchanged the unit during the procedure. The exchange of the heater cooler did not delay the surgical procedure. There was no harm or blood loss associated with this occurrence.
 
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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 (Section G)
SAME
Manufacturer Contact
douglas patton
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key8216927
MDR Text Key132228878
Report Number1828100-2019-00007
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2019
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2008
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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