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 Date 08/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The field service representative (fsr) verified that the pump was displaying "failure 5." he replaced the roller pump central processing unit (cpu)/control printed circuit board assembly (pcba).The device 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 set-up of the device for a cardiopulmonary bypass (cpb) procedure, the pump was displaying "failure 5".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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Updated block: h6.The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed that the central processing unit (cpu) control board was reporting a 'failure 5' error message during operation.He observed the cpu control board to fail six out of 10 times.When replacing the cpu with a lab use only board the pump function as intended, indicating that the user facility's cpu control board was bad.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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