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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 Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Per the manufacturer's technical support specialist, there was a blanket flow light that was coming on.During his trouble shooting he saw the cpg light was on and the three speed lights came on.Per the user facility's biomedical technician, he found the solenoid valve to be shorted causing the f4 fuse to be blown and the k1 microcontroller relay to be defective.
 
Event Description
It was reported that the unit could not start in cardioplegia (cpg) mode and was alarming.No other details regarding the nature of this event were provided.
 
Manufacturer Narrative
The reported complaint was confirmed via information received from the manufacturer's subsidiary.No parts were returned for further evaluation.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 Key10058378
MDR Text Key199122509
Report Number1828100-2020-00194
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
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2020
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 Received06/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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