TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER
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Model Number 16402 |
Device Problem
Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The field service representative (fsr) verified the reported issue.Overspeed 1 error message immediately appeared on the display and pump did not rotate when turned on.He tried replacing the pump driver board however the error still occurred.The suspect part was returned to the manufacturer for further evaluation.
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the device displayed an "over speed 1" error.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed an "overspeed 1" error.The motor was replaced with a lab use only motor and operated normally determining that the customer motor was the cause of the error message.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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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