TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS 8000
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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 Date 07/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The fsr replaced the broken occluder tongue.The unit operated to the manufacturer's specifications.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 field service representative (fsr) reported that during preventive maintenance (pm) of the device, the occlusion tongue was broken.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the molded pump tongue to be broken into three pieces.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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