• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS TCM II HEATING AND COOLING SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSARNS TCM II HEATING AND COOLING SYSTEM
Type of DeviceCONTROLLER, 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 Key5935775
MDR Text Key54660687
Report Number1828100-2016-00601
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4415
Device Catalogue Number4415
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/29/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-