TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 ROLLER PUMP
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Model Number 16402 |
Device Problem
Material Too Rigid or Stiff (1544)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The field service representative (fsr) was at the customer facility performing preventative maintenance when he discovered the occlusion knob was stuck halfway between fully occluded and unoccluded.The fsr removed the occlusion knob, cleaned and regreased it.Roller pump is within manufacturer's specifications and is ready for clinical use.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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It was reported that during preventive maintenance (pm) of the device, the user facility called and requested the pump to be fixed.Roller pump had a frozen occlusion knob.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.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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