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 03/11/2022 |
Event Type
malfunction
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Event Description
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During testing of the device at the service center, the service repair technician (srt) reported that one of the elbow fittings 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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Manufacturer Narrative
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Per the srt, in the process of troubleshooting the thread was found to be distorted on the machined housing at the fitting.
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Manufacturer Narrative
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Updated block: h6 the reported complaint was confirmed.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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