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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS TCM II HEATING AND COOLING SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING

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TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS TCM II HEATING AND COOLING SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING Back to Search Results
Model Number 4415
Device Problem Device Alarm System (1012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The cooler heater unit was repaired by the perfusion group's biomedical engineer (biomed). The biomed replaced the flow switch and discarded the suspect defective part, therefore no part will be returned to the manufacturer for evaluation. The unit operated to manufacturer specifications and was returned to clinical use. Per follow-up with the biomed and ccp: there were no leaks observed, no issue with cooling or heating of the unit, no knowledge of patient infection that may be associated with the cooler heater and the water in the unit was clean. 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 perfusionist (ccp) stated there was a "low flow to blanket light" alarm on the cooler heater unit. 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.
 
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Brand NameSARNS TCM II HEATING AND COOLING SYSTEM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5584527
MDR Text Key43546932
Report Number1828100-2016-00258
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 04/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4415
Device Catalogue Number4415
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2006
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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