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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 SYSTEMS CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING

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TERUMO CARDIOVASCULAR SYSTEMS, CORP. SARNS TCM II HEATING AND COOLING SYSTEMS CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING Back to Search Results
Model Number 4415
Device Problems Corroded (1131); Use of Device Problem (1670)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). This has been an on-going issue prior to january 20, 2014. The reported complaint is confirmed. The user facility provided a photograph which shows the rusting cooling bar. The unit was functional. The unit is over 13 years old. The manufacturer's technical services advised the customer on how to clean the unit. The customer has been using cidex to clean the unit. The customer stopped using this product (cidex) about a year ago and started using what the manufacturer recommends (interchlor). 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

It was reported that during the use of the device for a non-clinical activity, the cooler heater cooling bar was rusting. The cooling bar rusting has been an on-going issue. Customer noticed this during cleaning process. There was no patient involvement.

 
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Brand NameSARNS TCM II HEATING AND COOLING SYSTEMS
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 Key5719938
MDR Text Key47291491
Report Number1828100-2016-00417
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 HEALTH PROFESSIONAL
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 Received06/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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