TERUMO CARDIOVASCULAR SYSTEMS CORP. 6 INCH ROLLER PUMP FOR ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1
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Model Number 801041 |
Device Problems
Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is related to emdr #1828100-2016-00150.The reported complaint was confirmed.During the laboratory evaluation, the reported issue was duplicated.The product surveillance technician (pst) observed the unexpected belt slip messages, likely cause was grease/oil found on gut pulley, with potential migration to the belt and the motor pulley.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a follow-up emdr will be filed accordingly.
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Event Description
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The service repair technician (srt) reported that during routine testing of the device at the service center, a "belt slip" error intermittently activates with no load on the roller pump.There was no patient involvement.
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Manufacturer Narrative
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Service records show the bearing has not been replaced since initial manufacture, indicating the pump still had the generation 1 bearing.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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