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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Model Number 164925 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).As per field service representative, a 'pump not primed' error message was displayed and the pump not prime light was illuminated.There were no issues with heating or cooling and no leaks were observed.The customer chose not to have the unit serviced.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.(b)(4).
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, there was black debris in both the large and small tank.There was no delay, no blood loss, nor adverse consequences to the patient.
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Search Alerts/Recalls
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