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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING Back to Search Results
Model Number 4415
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Per the biomedical technician, he was calling on behalf of a customer in india with the information he was provided.There is uncertainty around the manufacturer of the unit.Further diligence is being done to obtain more information.
 
Event Description
It was reported that the dual temperature sensor was not working.No other details regarding the nature of this event were provided.
 
Manufacturer Narrative
Corrected block: name and address.
 
Manufacturer Narrative
The reported complaint was not verifiable.Diligence for part return and additional information was unsuccessful.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 Name
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key7428788
MDR Text Key105916746
Report Number1828100-2018-00187
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4415
Device Catalogue Number4415
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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