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

Model Number 4415

Device Problems Corroded (1131); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.The user facility¿s biomedical engineer (biomed) troubleshot the issue to solenoid valve 5.This valve was intermittently making a noise.The biomed removed the valve and cleaned it out.It was then placed back into the unit.The biomed was concerned it was still making some noise and tried to order a new valve.The field service representative (fsr) was unable to duplicate the noise.The fsr replaced the valve per customer request.As the biomed cleaned the valve and found the noise had improved.Visual inspection of the returned valve by the investigator determined corrosion is present inside the valve along the diaphragm.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, the cooler heater unit was noisy.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.

• Brand Name: SARNS TCM II HEATING AND COOLING SYSTEM
• Type of Device: CONTROLLER, 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 Key: 5720360
• MDR Text Key: 47234161
• Report Number: 1828100-2016-00424
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1