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 Problem Insufficient Heating (1287)

Patient Problem No Information (3190)

Event Date 01/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Diligence attempts are still ongoing to obtain surgery related information.

Event Description

The customer reported that the unit would not rewarm and kept alarming over temperature.

Manufacturer Narrative

(b)(4).

Event Description

Additional information indicated that the reported event occurred during use of the device for a cardiopulmonary bypass (cpb) procedure.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.Per clinical review: according to the user facility's perfusion staff, this incident occurred on (b)(6) 2017.During cpb and during the start of rewarming of the patient, the heater cooler was placed in the rewarm mode, but the water exiting the unit remained cold.Even though the outlet water was not being warmed, an overtemp alarm sounded and kept alarming.Due to the behavior of the unit, the perfusionist elected to change out the unit with a replacement device and rewarming was completed and the patient was weaned from cpb without further issue.The local field service representative (fsr) visited the center to repair the unit days after the procedure.He found a stuck valve which allowed cold water to mix with warm and this prevented the water to be warmed to the user desired temperature.In addition, the stuck valve lead to stagnant water near the internal temperature sensor and this lead to a localized volume of water to heat up to 42 degrees c and set off the overtemp alarm.This localized volume of water was isolated from the outlet water lines.The procedure was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The reported complaint was confirmed.The field service technician (fsr) found that valve 3 solenoid was stuck in position causing water to circulate incorrectly.The valve was replaced with new part and the replaced part was discarded on site.The unit operated to the manufacturer's specifications.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: 6343271
• MDR Text Key: 68104046
• Report Number: 1828100-2017-00079
• 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,Followup
• Report Date: 05/09/2017

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/27/2017; 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2002
• 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