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
False Alarm (1013)
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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).
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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 roller pump has a problem with a diode in pump power board, causing battery back-up light to remain on.The unit was a spare roller pump.There was no patient involvement.
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Manufacturer Narrative
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The field service representative (fsr) replaced the shorting link, heat sink, cable assembly and the diodes.The unit operated to manufacturer specifications and was returned to clinical use.The suspect parts were returned to the manufacturer for further evaluation.During the laboratory evaluation, one of the two diodes mounted to the heatsink was shorted electrically.No problem was found with the other diode.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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