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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 Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The reported complaint was confirmed.Per the user facility's laboratory technician, the unit has been retired from clinical use and is only used for experiments in the animal lab.He believes that it was a "03" error message being displayed every time the unit is primed.The error message is only displayed on one of the channels.After changing the water he poured in a splash of bleach resolving the issue.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, one of the channels on the heater cooler was not pumping water.This event occurred in (b)(6) 2018.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was not verifiable.
 
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Brand Name
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key7477556
MDR Text Key107193279
Report Number1828100-2018-00220
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K071521
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
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
Date Manufacturer Received05/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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