TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO 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 01/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported complaint was confirmed.During the laboratory evaluation, the report issue was duplicated.Per the product surveillance technician (pst) the "belt slip" occurs at the pump jam test, due to grease/oil from the bearings had leaked onto the belt and associated pulleys.The pump has not had the bearing replaced since initial manufacture, indicating the pump has a generation 1 bearing.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 supplemental report 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, the roller pump jam function does not activate properly per instructions in the service bulletin.Per the srt, a "belt slip" error was also observed.There was no patient involvement.
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Search Alerts/Recalls
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