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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TCM HEATING AND COOLING SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING Back to Search Results
Model Number 4415
Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The reported complaint was confirmed. Follow up with the field service representative (fsr) determined the customer did not know the last time the cooler heater unit was cleaned/maintenance. The unit was drained and debris was found inside the unit. Per the customer the debris looked like "rocks;" fsr informed customer that this is build-up from not cleaning the unit per the operator's manual, which the customer admitted to misplacing. The fsr sent the customer information for descaling and cleaning the unit. In addition the fsr recommended to the customer to descale the unit three times to ensure the unit was fully cleaned as the unit had not been maintained. The fsr also recommended sending the unit to the manufacturer for a full maintenance check but the customer declined this option. The service history shows the customer has not had a documented preventative maintenance (pm) inspection since september 2010. As the fsr has communicated appropriate actions to the customer, no further follow-up is required. 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 (b)(4). ".

 
Event Description

It was reported that during the use of the device for a non-clinical activity, the cooler heater unit had foul water and debris in the bottom of the water tank. There was no patient involvement.

 
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Brand NameSARNS TCM HEATING AND COOLING SYSTEM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson rpad
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5720291
MDR Text Key47252465
Report Number1828100-2016-00422
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
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 HEALTH PROFESSIONAL
Device MODEL Number4415
Device Catalogue Number4415
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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