TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
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Model Number 500AVHCT |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/03/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the screen of the cdi 500 blood parameter monitor was dead, the screen went black, and they noticed a burning electrical smell.The device was shut down.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.Per clinical review: during cpb, the cdi 500 display totally blanked (loss of display) and a burning smell was observed.The monitor was powered-down and not used for the remainder of the procedure.A back-up unit was brought in for the remainder of the case.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.
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Manufacturer Narrative
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The complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) found blood parameter monitor failed to boot up properly, the screen was black and single board computer (sbc) printed circuit board assembly (pcba) was beeping, there was a smell of burnt/blown electrical components.The hematocrit saturation module (h/sat) servo card was found to be defective, it had a shorted and blown out component (c11) close by components of u11 and u4 possibly affected as well.This component (c11) being shorted caused the +12v & -12v direct current (d/c) of the system voltage too drop to around +5, and -7.99v dc, producing the blank screen on startup, beeping of the sbc pcba.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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Manufacturer Narrative
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The service repair technician (srt) installed a new hematocrit saturation module (h/sat) servo card on monitor and it successfully passed startup self test to manufacturer's specifications with no errors.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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Manufacturer Narrative
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(b)(4).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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