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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 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 CORPORATION 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 Problems Fracture (1260); Pumping Stopped (1503); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The field service representative (fsr) confirmed the noisy pump and the error message. He drain the unit and disassembled the pump head. There were two fins broken off of the impeller and a tie wrap in the head. A new impeller was installed. The unit operated to the manufacturer¿s specifications. The product surveillance technician (pst) confirmed that the impeller was broken. The defective part was returned to the manufacturer. 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 (cpb) procedure, the heater cooler made a loud noise and stopped pumping at the end of the case. An 'pump not primed' alarm was displayed when the main pump was started. 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 clinical review: the perfusion team had an incident regarding the heater cooler device. Towards the end of the cpb procedure, the perfusionist (ccp) heard a loud noise from the heater cooler and then it stopped pumping water to the heat exchanger/oxygenator. He attempted to start the main water pump again, and the 'pump not primed' error message occurred. The patient was warm at that point, but to maintain the appropriate warm temperature, the perfusionist made the decision to change out the unit to another unit. This changing of the equipment did not delay the surgical procedure. The patient was weaned from cpb without issue, and there was no blood loss. No harm was observed.

 
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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 CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
katie hoyt
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key6938764
MDR Text Key90252062
Report Number1828100-2017-00461
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 10/10/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2017
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? Device Returned To Manufacturer
Date Returned to Manufacturer09/21/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/08/2010
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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