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
Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Per fsr, the minimum and maximum labels are no longer available.The unit operated to the manufacturer's specifications.
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Event Description
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The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the unit had a missing label that identifies the minimum and maximum fill levels.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.As per the field service representative (fsr), there were no parts available for replacement due to part obsolescence.The end-user was still using the unit as a back-up.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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Search Alerts/Recalls
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