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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING Back to Search Results
Model Number 4415
Device Problem Device Alarm System (1012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The reported problem could be a switch issue or a sensor problem. As per biomed, the heater-cooler was being prepped for surgery when the tech said it overheated. They are having pump alarms while they are getting good flow through all three sets of hoses.

 
Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the heater cooler unit keeps on alarming. It is thought that the pump has an air lock. 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.

 
Manufacturer Narrative

(b)(4). The reported complaint was confirmed. The issue was verified by the field service representative (fsr). He found that the pressure sensor in the base of the unit was clogged with debris. He removed the debris and replaced the pressure sensor as a precaution. The unit operated to the manufacturer's specifications. No part will be returned to the manufacturer for further analysis, as it was disposed of at the user facility. Per follow up with the user facility biomedical engineering technician (bmet), before the fsr serviced the unit, they flushed it three times to remove any scale deposits. After the repair, the unit was brought to six parts per million (ppm) chlorine. The bmet reminded the perfusion staff to keep the chlorine at six ppm. There have been no additional issues since the repair. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

 
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Brand NameSARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
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
eileen dorsey
6200 jackson road
ann arbor, MI 48103
7347416074
MDR Report Key6094094
MDR Text Key59979626
Report Number1828100-2016-00720
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/10/2016
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? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/10/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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