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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 4416
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Per subsidiary, the unit was leaking inside of the tcm at the cardioplegia angled connector. The subsidiary applied silicone to the fitting which stopped the leaking and the unit worked properly. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

 
Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the fitting of the heater cooler had a crack that caused the water to leak. As a result, an alternate device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.

 
Manufacturer Narrative

The reported complaint was confirmed. Per the manufacturer's subsidiary, the elbow connector was replaced and the unit is operating to the manufacturer's specifications. 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 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 Contact
katie hoyt
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key6775211
MDR Text Key82602959
Report Number1828100-2017-00353
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeSA
PMA/PMN NumberK883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4416
Device Catalogue Number4416
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/13/2011
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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