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

Model Number 4415

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This has been an on-going issue prior to january 23, 2014.The reported complaint was confirmed.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 (b)(4) to clean the unit.The customer stopped using this product ((b)(4)) about a year ago and started using what the manufacturer recommends ((b)(4)).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.

• Brand Name: SARNS TCM II HEATING AND COOLING SYSTEMS
• Type of Device: CONTROLLER, 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 Key: 5719976
• MDR Text Key: 47220155
• Report Number: 1828100-2016-00418
• 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: Other
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2003
• 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