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 Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the heater cooler alternating current a/c "went out".The unit was immediately changed out.There was a 5 minutes delay.The surgical procedure was completed successfully.There were no reported adverse consequences to the patient as a result of this event.As per clinical review on 08-nov-2016: the clinical specialist spoke with the perfusion technician regarding the incident.The perfusion technician stated that during a dose of cold cardioplegia, the heater cooler controls blanked and it appeared that the alternating current (a/c) power was lost.A back-up unit was brought to the operating room (or) in order to complete the cardioplegia dose and the procedure.The dose of the cardioplegia was delayed.The procedure was also delayed by 5 minutes as the back-up unit was brought to the or.The delay did not cause any impact to the patient.

Manufacturer Narrative

The field service representative (fsr) tested the unit and could not reproduce power loss.The unit performed 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: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6121942
• MDR Text Key: 60965666
• Report Number: 1828100-2016-00758
• 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,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• 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: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2002
• 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