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
Failure to Power Up (1476)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The field service representative (fsr) verified the issue.The pump circuit breaker was turned on but the display did not illuminate and the pump could not function.The fsr replaced the driver board.The unit operated to the manufacturer's specifications.The suspect device was sent back to the manufacturer for further evaluation.
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Event Description
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It was reported that during priming of the device for a cardiopulmonary bypass (cpb)procedure, the pump on the heart lung machine (hlm) did not power up.As a result, an alternate device was employed.No other details regarding the nature of this event were provided.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician duplicated the reported complaint.When the customers printed circuit (pc) assembly was installed into a lab use only roller pump, the roller pump would not function.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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