Catalog Number 114746L |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)
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Event Date 07/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The patient is 67 or 69 years of age.Should addition relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that approximately 15-30 minutes during treatment with a revaclear dialyzer, the dialysis machine generated several "air in blood" alarms.Eventually the alarms cleared but no air or bubbles could be observed within the extra-corporeal circuit.As a result of the alarms, the patient experienced shortness of breath and chest pain.The patient was placed in minimum ultrafiltration rate and in a trendelenburg position and received saline due to hypotension.Reportedly the symptoms dissipated.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available for evaluation since it was discarded at customer site.However the customer stated that there was no visible defects on the dialyzer.Should additional relevant information become available a supplemental report will be submitted.The device was manufactured from 27apr2018 through 28apr2018.
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Search Alerts/Recalls
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