TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
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Model Number 500AHCT |
Device Problem
Smoking (1585)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation is in progress, but not yet concluded.
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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 user saw and smelled smoke from the unit when it was turned on.The unit was turned off and not used throughout the case.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 there to be evidence of overheating inside of the hematocrit saturation (hsat) module.The hsat servo card was disassembled and there was a damaged capacitor that appeared to have been overheated.He also noted that he could smell possible overheating had occurred.The service repair technician (srt) installed a new hsat servo card and monitor successfully passed power on self test without the smell of smoke.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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