MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO TCM II COOLING AND HEATING SYSTEM

Model Number 4415

Device Problems Partial Blockage (1065); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, there was lack of water flow to the patient blanket.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.

Manufacturer Narrative

This complaint is related to mdr #1828100-2015-00047.The reported complaint was confirmed.The field service representative (fsr) verified the water flow issue through the warming blanket.The fsr changed the mixing valve 2 due to corrosion and lack of descaling the system as required every six months.The fsr descaled the unit several times in order to regain flow to the warming blanket outlet of the cooler heater unit.After rinsing the unit, flow was restored.The fsr noted that the unit showed that the proper maintenance/cleaning schedule for the system was not being followed and attributed to the build-up of scale in the water system.This unit is not under contact for preventive maintenance (pm) by the manufacturer.A third party service company completed the pm on (b)(6) 2014.There will be no part return as the hospital staff disposed of the part.The unit operated to manufacturer specifications for the water flow portion and electrical safety only and was returned to clinical use.No additional action will be taken at this time.

• Brand Name: TERUMO TCM II COOLING AND HEATING SYSTEM
• Type of Device: TCM II COOLING AND HEATING SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4574746
• MDR Text Key: 5559552
• Report Number: 1828100-2015-00195
• 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 Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• 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
• Date Manufacturer Received: 02/26/2015
• 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