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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORP. HX2 TEMPERATURE MANAGEMENT SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS. Back to Search Results
Model Number 809810
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  No Answer Provided  
Manufacturer Narrative
(b)(4). Note: type of reportable event: fda safety communication. This complaint is related to emdr #1828100-2016-00151, #1828100-2016-00152 and #1828100-2016-00154. Per the product surveillance supervisor, there will be no surgery related or customer information as these complaints are not for a specific event. Diligence for additional information cannot be performed. This complaint is not verifiable. There have been no confirmed complaints to the manufacturer where the hx2 heater cooler unit was found to be the cause of nontuberculous mycobacterium (ntm) infections. The manufacturer provides established requirements for sanitization and instructions for correctly maintaining the system. These are clearly outlined in the operators manual and the hx2 temperature management system cleaning guide. Included in the requirements is a daily sanitization procedure with a check of the chlorine levels, weekly cleaning and sanitization and a semiannual descaling procedure. Decontamination is required whenever biofilm is evident in the system (discoloration or cloudiness in the water system). If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Event Description
A u. S. Food and drug administration (fda) safety communication was issued for nontuberculous mycobacterium (ntm) infections associated with heater cooler devices. This complaint is specific to temperature management system (hx2) heater cooler device. This complaint will also include a journal article from centers for disease control and prevention on 'transmission of mycobacterium chimaera from heater-cooler units during cardiac surgery despite an ultraclean air ventilation system' that was released ahead of print for the june 2016 issue (volume 22, number 6). There was no patient involvement.
 
Manufacturer Narrative
It was found that the sanitizer listed in the cleaning guide and instructions for use (ifu) was obsolete. Replacement sanitizer has been identified and the ifu and cleaning guide will be updated. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Manufacturer Narrative
Per fda, the potential root causes of contamination from heater-cooler devices includes ntm bacteria transmitted through the air (aerosolization), laminar flow disruption and the heater-cooler design. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
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Brand NameHX2 TEMPERATURE MANAGEMENT SYSTEM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS.
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
katie hoyt
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5484346
MDR Text Key39986702
Report Number1828100-2016-00153
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number809810
Device Catalogue Number809810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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