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 4415 |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Per the user facility's biomedical engineer, he ran the machine in 'rewarm mode' with tubing and it warmed up to 42 degrees celsius and was holding at that temperature.There will be no parts to return since the issue has been resolved.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 (cpb) procedure, the unit would not warm.There was no delay, no blood loss, nor adverse consequences to the patient.
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Search Alerts/Recalls
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