TERUMO CARDIOVASCULAR SYSTEMS CORP SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
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Model Number 6379 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.The field service representative (fsr) confirmed the display randomly turned off, blinking and resetting the unit.The membrane panel was separating causing a short that reset the unit.The pump display / membrane panel assembly was replaced.The unit operated to the manufacturer¿s specifications.
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the centrifugal unit turns off randomly.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) was not able to duplicate the reported complaint.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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