Model Number 16418 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).As per the subsidiary, tubing was used during calibration and the error occured when the device was in the fully occlude position.
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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 venous line occluder was unable to fully occlude the tubing.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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Evaluation is in progress, but not yet concluded.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) attached a laboratory use occluder head to the returned occluder and it was able to fully occluded.
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Manufacturer Narrative
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The reported complaint was not confirmed.The service repair technician (srt) attached the occluder to the service depot test equipment and the complaint was not duplicated.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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Search Alerts/Recalls
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