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

Model Number 4415

Device Problems Insufficient Cooling (1130); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per follow-up with the ccp: they have no knowledge of patient infection that may be associated with the cooler heater unit, they use bottled water in the unit, they do not routinely culture the water in the unit, the ice block is defrosted daily, no fault indicator lights were illuminated, the water was not cloudy or discolored, and the unit was not leaking internally or from the external connectors.The field service representative (fsr) spoke to ccp and the ccp stated when he walked into room (can't remember date) expecting the cooler heater unit to have ice there was none.The ccp checked settings and believes it was not programmed correctly.He set it up as he usually does and it is now operating correctly.The ccp believes it may be a user error or intermittant because he thinks he saw it happen before but would like fsr to check out the unit.The fsr confirmed the complaint.The green ice-making light was on but the compressor was not running.The unit was turned off and back on, then the compressor ran after a normal four minute delay.The fsr tested the compressor delay board and main board and found no issue.He tested the ice making sensor and during testing, the compressor started up and ran normally.The fsr corrected intermittent p65 connection and the unit appears to be working properly.The customer will advise if problem reoccurs.The unit operated to manufacturer specifications and was returned to clinical use.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 set-up of the device for a cardiopulmonary bypass procedure, the cooler heater unit was not making ice.The device was not changed out, as they continued to use the unit.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• Brand Name: SARNS TCM II HEATING AND COOLING SYSTEM
• 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: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5960825
• MDR Text Key: 55342337
• Report Number: 1828100-2016-00628
• 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: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• 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: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2000
• 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