TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL
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Model Number 16402 |
Device Problem
Break (1069)
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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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The fsr replaced the tongue and the unit operated to the manufacturer's specifications.The suspect device was sent to the manufacturer for further evaluation.
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Event Description
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The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the tongue of the roller pump was found broken.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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