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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 Problems Device Reprocessing Problem (1091); Device Contamination With Biological Material (2908); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). This complaint is being submitted in response to u. S. Food and drug administration (fda) request. This complaint is related to emdr #1828100-2016-00326. The user facility¿s biomedical engineer (biomed) stated they perform semiannual preventative maintenance and electrical safety testing every six months. The operating room (o/r) staff performs the chlorine and cleaning maintenance. The biomed did not experience issues with cooling or heating and no leaks were observed. The reported complaint was confirmed. The field service representative (fsr) stated the customer have been cleaning the unit twice a day. The fsr reviewed the proper cleaning and de-scaling procedure with the perfusionist (ccp) and the biomed. The fsr walked through the steps in the cleaning guide and reviewed the required chemicals need to maintain the unit. 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

It was reported that during the use of the device for a non-clinical activity, the heater cooler unit seemed to have a lot of algae. They clean the unit twice a day and it still seems to have this issue. There was no patient involvement.

 
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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
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5649861
MDR Text Key45199914
Report Number1828100-2016-00327
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK071521
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 05/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/12/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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?
Event Location No Information
Date Manufacturer Received05/05/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/28/2009
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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