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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 Restricted Flow rate (1248); Excessive Cooling (2932)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
The field service representative (fsr) performed preventive maintenance (pm) and retested the heater cooler with a full ice block.The unit operated to the manufacturer's specifications.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the unit was making too much ice to the point where it restricted the flow.As a result, water was added to melt the ice.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
 
Manufacturer Narrative
The reported complaint could not be confirmed.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 Key9476924
MDR Text Key199114128
Report Number1828100-2019-00659
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,health
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
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 Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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