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 Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per field service representative (fsr), ice making function is satisfactory.The unit is operating within terumo specifications.

Event Description

It was reported that the heater cooler (tcm ii) produced ice block that is too large.No other details regarding the nature of this event were provided.Diligence attempts are still ongoing in obtaining the event information.

Manufacturer Narrative

As per medical facility employee, the reported issue was noticed in the morning prior to putting the case in the room.The user reported the problem occurs all the time, unless the compressor to make the ice block is shut off.Issue is mitigated by partially defrosting the unit before use.The surgery was completed successfully.The user further noted that there was no sequence of events that led up to the failure, just continued ice block over production, because the sensor is not working.The ice block is defrosted after every use and now partially before use.Maintenance process is according to manufacturer's guidelines, and preventive maintenance is done every 6 months.The user further noted that if ice block is too large then heating and cooling will not occur, because there is no water flow.

Event Description

Additional information was received indicating that the problem was discovered during non clinical activity.

Manufacturer Narrative

(b)(4).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: 6230179
• MDR Text Key: 64371791
• Report Number: 1828100-2017-00008
• 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: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• 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: 03/22/2017
• 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