TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
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Model Number 895208 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The reported complaint was confirmed.The srt found that one of the tubes from the o2 sensor upgrade kit was obround which caused the epgs leak test to fail.The srt replaced the tubing.The unit operated to the manufacturer's specifications.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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Upon receipt of the device, the service repair technician (srt) reported that one of the tubes from the electronic patient gas system (epgs) oxygen (o2) sensor upgrade kit was leaking air during the leak test above 10 cubic centimeters per minute (cc/min).There was no patient involvement.
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