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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 Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2018
Event Type  malfunction  
Manufacturer Narrative
The reported issue was discovered when the user facility's biomedical engineer was cleaning the unit.
 
Event Description
It was reported that during use of the device for a non-clinical activity, black pieces of the rubber hose inside the unit were found in the tank.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was not verifiable.Multiple diligence attempts for part return were unsuccessful so no evaluation could be done.Per the user facility's biomedical engineer, they cleaned the heater cooler by flushing it out, 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.
 
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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 Key8161276
MDR Text Key130485970
Report Number1828100-2018-00640
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 health professional,user faci
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
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 Received03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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