TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER
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Model Number 16402 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/04/2018 |
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 pumps occlusion could not be adjusted.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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During laboratory analysis, the product surveillance technician (pst) observed the occlusion knob to not turn.The slot on the pump guts where the molded tongue makes contact was worn.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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