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 Consequences Or Impact To Patient (2199)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The fsr tested the unit and could not verify the reported issue.The unit performed to 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.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the unit failed to heat.The product was changed out and the surgery was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.As per clinical review on 29-mar-2017: the perfusionist has installed valves in their external water hoses and this allows them to deliver warm water to the cardioplegia circuit (hot shot) as warm water is delivered to the oxygenator during rewarming of the patient.When rewarming was attempted (with attempts to also warm the cardioplegia water), the water in the hoses was not rewarming.As troubleshooting attempts were not successful, the team elected to change out the unit to complete the rewarming process and complete the procedure.After the procedure, the local manufacturer's field service representative (fsr) visited the site and inspected and tested the unit and no functional issues were found.It was determined that the perfusionist either adjusted the external valves incorrectly or the valves stuck in the closed position.This unit has been used since this procedure and no issues have been observed.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

• 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: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6486385
• MDR Text Key: 72810740
• Report Number: 1828100-2017-00173
• 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: Other
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• 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: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2000
• 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