TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP
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Model Number 16402 |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is related to emdr #1828100-2015-00253.Per the srt, the indicator dial will be replaced with new part and returned for evaluation.
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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's indicator dial silks-creen increment markings are worn off.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.The service repair technician (srt) replaced the indicator dial with new part.The srt performed preventive maintenance (pm) and verification/release test.The roller pump operated to the manufacturer's specification.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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