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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.

 
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Brand NameSARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer (Section G)
SAME
Manufacturer Contact
douglas patton
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key9476924
MDR Text Key199114128
Report Number1828100-2019-00659
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device Was Involved in the Event
0 PatientS WERE 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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/17/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/11/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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