TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
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Model Number 6382 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 11/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility had replaced the flow sensor with one from their stock.The fsr verified the broken clip but did not test for flow reading.He did replace the user facility¿s stock with a new flow sensor.The unit operated to the manufacturer¿s specifications.The suspect device was returned to the manufacturer for further evaluation.
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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 clip that secures the flow sensor to the flow module was broken and no flow reading was being displayed.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the cover on the flow sensor to not stay closed as the front clip that holds the cover shut did not seem as tightly sprung as a newer clip would be.While the water loop was inserted into the flow sensor, he had to hold the flow sensor closed in order to receive a flow reading.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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