TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
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Model Number 811474 |
Device Problem
Decoupling (1145)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/13/2020 |
Event Type
malfunction
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the centrifugal head became decoupled from the centrifugal motor.The end user noticed decoupling, reattached the centrifugal pump and the decoupling was resolved.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.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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Per clinical review: on march 13, 2020, during cardiopulmonary bypass (cpb), the perfusion team saw that the sp45 had decoupled from the drive motor on the heart lung machine (hlm).The system was set up and primed without issue for the procedure on (b)(6) 2020.The flow and revolutions per minute (rpm) during the procedure were appropriate, but the end user noticed during the cpb that the connection was not complete on the drive motor, as stated by the end user 'noticed the decoupling, then reattached the centrifugal pump'.It is not known what preceded the end user noticing the issue, but patient forward flow was consistent.The end user was able to recouple (properly attach) the centrifugal disposable to the drive motor without issue, and without a delay in the continuation of the surgical procedure.There was no harm or blood loss associated with the event.
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Search Alerts/Recalls
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