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 Obstruction of Flow (2423)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint is confirmed by a manufacturer certified biomed.The biomed followed manufacturer's technical support advice to clean unit and check for bubbles.No bubbles but did find lint blocking the trap.Cleaned the machine and working as intended.No further issues.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

The user facility biomedical engineer (biomed) reported that during preventive maintenance (pm) of the device, the cooler heater unit was not making ice.This is a back- up unit.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: 5720023
• MDR Text Key: 47220473
• Report Number: 1828100-2016-00419
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Biomedical Engineer
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Yes
• 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: 07/31/2006
• 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