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); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the (b)(6): they defrost the ice block every other day, there were no fault indicator lights illuminated, their chlorine maintenance schedule is checked daily to maintain (b)(4) parts per million (ppm), the water was not cloudy or discolored, and they have no knowledge of any patient infection that may be associated with the cooler heater unit.Per the (b)(6), the cooler heater unit lines were checked for kinks and to verify bridge was not open.The (b)(6) touched lines physically to verify temperature was reading properly and checked to see if water was coming out of "defrost bar", which it was not.After it was taken out of service, unit was unplugged and plugged back in.The compressor did start and by morning an ice block was formed.It was put back into service.The reported complaint was confirmed.The fsr instructed the customer of the instructions for use (ifu) directions on making the ice block, a minimum of 8 hours is required to make a (b)(4) pound block of ice which is sufficient to run a normal bypass procedure.Fsr advised the user facility¿s biomedical engineer (biomed) to leave cooler heater unit running overnight to make ice.Follow up with the biomed found the cooler heater unit made 1/2 block of ice by the end of the day and a full block of ice had formed by the next morning.No service call was required.The biomed will continue to monitor the cooler heater unit.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 procedure, the cooler heater unit was fully defrosted in the morning, but was needed for a case.The compressor was turned on and running for approximately three hours before case.When cooling was needed, the customer noticed no ice had formed in the tank and cooling wasn't possible.The user attempted adding ice to tank, but not cooling enough.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 the clinical summary on (b)(6) 2016: according to the complaint details provided by the field service representative (fsr), the customer reported the cooler heater unit was fully defrosted in the morning, but was needed for a case.The compressor was turned on and running for approximately three hours before case.When cooling was needed, the user noticed that no ice had formed in the tank, therefore would not cool.The users attempted adding ice to tank, but was not cooling effectively enough.The unit was swapped out for a backup unit and case was completed successfully.The fsr informed the customer that three hours was not enough time for the compressor to create an ice block.Follow-up with the customer showed that after being left to make ice overnight, the unit had a full block of ice.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

• 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: 5935775
• MDR Text Key: 54660687
• Report Number: 1828100-2016-00601
• 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
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• 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: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2010
• 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