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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 Problems Fluid Leak (1250); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2010
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The field service representative (fsr) visited the hospital and found two leaks. One was at the front of the unit where the hoses enter the base. The unit was leaking from a hose clamp. The second leak was at valve 6. The polyvinyl chloride (pvc) connector was leaking where it meets the assembly. The fsr noted specifically how difficult these locations are accessible to evaluate. The unit was run in all modes for an extended period of time with no leaks. The system is no longer leaking, and performs to specifications. The fsr noted that the hospital had never done preventative maintenance (pm) or descaling until very recently. The customer would only drain the units and refill them. As a result of the many years without pm, the unit had collected mineral deposits around many of the fittings/connections. When the user began to descale the unit these mineral deposits began to break down, and the resulting leaks occurred. A mdr remediation activity related to manufactured devices with a fda product code ¿dwc: controller, temperature, cardiopulmonary bypass heater cooler" was conducted. This report is a result of the ¿heater ¿ cooler response remediation protocol 02-jun-2016. ¿.

 
Event Description

After use of the device for a cardiopulmonary bypass procedure, the user reported the cooler heater unit was leaking water in the defrost mode. There were no reported 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 Key5719696
MDR Text Key47210016
Report Number1828100-2016-00411
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
Type of Report Initial
Report Date 06/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER HEALTH CARE PROFESSIONAL
Device MODEL Number4415
Device Catalogue Number4415
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 Received06/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/29/2002
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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