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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Model Number 4415 |
Device Problems
Device Inoperable (1663); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The field service representative (fsr) was able to verify the issue onsite.Troubleshooting of the heater cooler was completed by measuring voltages on the main printed circuit board (pcb).He removed p-5 pump and it work intermittently.The pump motor was hot.The main pump motor was replaced and tested.Unit meets manufacturer's specification.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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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the main pump will not turn on and there was an ¿it would not prime¿ alarm which caused the issue.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.
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Manufacturer Narrative
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Additional complaint information was received from the field service rep.The last maintenance for the device was march 14, 2017, and the device ice block is defrosted twice a week.The fault indicator lights illuminated stated "not prime led." 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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