TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
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Model Number 816571 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.
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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 pump was stuck and not rotating.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 loose roller guide screw contacting race and preventing gut rotation.Per data log analysis on 17-may-2018, only the pump log covers the incident date.On (b)(6) 2018 at 07:32:24 the pump reports a "belt slip jam status = true", stopping the pump.This occurs again at 07:33:35.At 07:33:48 the pump reports an "opto sensor disconnected/broke err = true", stopping the pump again.This occurs again at 07:35:55.The log confirms the complaint indicating a possible issue with the opto sensor.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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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