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

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.

• Brand Name: SARNS TCM 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 rpad; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5720291
• MDR Text Key: 47252465
• Report Number: 1828100-2016-00422
• 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: health professional,user faci
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1