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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 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 Device Contamination with Chemical or Other Material (2944); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Patient Involvement (2645)
Event Date 01/20/2014
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The reported complaint was confirmed. Manufacturer tech support staff advised the customer on how to clean the unit. The customer had been using cidex to clean the unit. The user facility stopped using cidex about a year ago and started using what manufacturer recommends (interchlor). The rubber hoses can deteriorate due to the chemical reaction with cidex. User error may have contributed to the particulate in the water. 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 set-up of the device for a cardiopulmonary bypass procedure, particulate was found in the water of the cooler heater unit. The device was not changed out as "maintain" mode was used for both cooling and rewarming. 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 CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5720687
MDR Text Key48155236
Report Number1828100-2016-00429
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
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
Date Device Manufactured08/22/2003
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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