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

Model Number 4415

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) tested operation of the unit and found flow to be normal.Unit was just cleaned and water became slightly murky after running in maintain and rewarm modes for 1/2 hour.Draining and refilling unit before making ice block was recommended.The unit operated according to manufacturer specifications and unit was returned to clinical use.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the main section of the heater cooler (tcm ii) failed to warm the patient.The unit was changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.As per clinical review on 18-nov-2016: the hospital has provided information regarding the incident and regarding patient involvement.During rewarming of the patient in the late stages of cpb, the perfusion team was not able to provide warm water (from tcm2) at an adequate flow rate to warm the patient to desired temperature.There were no leaks observed and the user stated that cleaning / maintenance was maintained per ifu guidance.The tcm2 was changed out with another cooling-heating device and rewarming was able to be accomplished.There were no error codes or audible tones to indicate an issue.

Manufacturer Narrative

The reported complaint was not confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
• 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: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6159312
• MDR Text Key: 62381763
• Report Number: 1828100-2016-00783
• 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,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2000
• 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