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 801041 |
Device Problems
Leak/Splash (1354); Pumping Stopped (1503)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Per the manufacturer's subsidiary, the belt looses friction and just spins on the shaft stopping the pump.This is a demonstration unit only and not used clinically.
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Event Description
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It was reported that during routine testing of the device at the manufacturing engineering center (mec), grease had leaked from the bearing and the pump stopped.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.Multiple diligence attempts by the manufacturer were unsuccessful in obtaining the part for evaluation.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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