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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 08/30/2018
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 heater-cooler had an incident during a cpb procedure with the patient cooling/warming side. The heater-cooler was set up and worked for the early part of the cpb procedure on (b)(6) 2018. During rewarming of the patient, the perfusionist had the heater-cooler give an "e08" error message on the patient side channel. The perfusionist had to the exchange the unit out, for he was unable to warm the patient with the e08 failure. The perfusionist proceeded accordingly with the working unit. The incident did not delay the surgical procedure, for the perfusionist was able to exchange the unit in a timely manner to give the surgical team time to perform the repair. There was no blood loss or harm associated with the event.
 
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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 Key7903393
MDR Text Key122155643
Report Number1828100-2018-00492
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 12/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/21/2018
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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