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

Model Number 4415

Device Problems Calcified (1077); Device Contamination with Chemical or Other Material (2944); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.The field service representative (fsr) found water line filter very dirty and blanket connections dirty with calcium deposits.He cleaned out water line filter and all hansen connectors located at the rear of the unit.After cleaning the unit, the fsr completed the pm.The unit operated to manufacturer specifications and was returned to clinical use.An mdr remediation activity related to manufactured devices with a u.S.Food and drug administration (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's biomedical engineer (biomed) reported that during preventive maintenance (pm) of the device, low flow was found on the cooler heater unit.There was no patient involvement.Further clarification of the complaint description per the field service representative's report indicated the "no flow to blanket" indicator light falsely turns on.

• 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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5721346
• MDR Text Key: 48161404
• Report Number: 1828100-2016-00438
• 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

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2003
• 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