Catalog Number 955558 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Hypovolemic Shock (1917)
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Event Date 05/27/2022 |
Event Type
Death
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Event Description
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It was reported that after 32 hours of continuous venovenous hemodiafiltration (cvvhdf) on a prismax machine, it was identified that the operator erroneously entered the pre-blood pump (pbp) flow rate into patient fluid removal (pfr) and set pfr at 1000 ml/h.The reported total fluid withdrawal level was 32 liters.The patient reportedly presented with anuria and circulatory instability due to hypovolemic shock.The patient was transferred to a nearby maximum care facility and ¿entered a health crisis¿ and subsequently passed away shortly afterwards.The cause of death was unknown.It was not reported if an autopsy was performed.No additional information is available.
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Manufacturer Narrative
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The serial number of the prismax machines were reported as (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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D4: the involved prismax machines were (b)(6), based on the event history log review.H10: the devices were evaluated on site by a qualified technician: both were found performing within specification and were returned to clinical service.The event history log review showed that the prismax machines behaved as intended and within the specification limits.It is unlikely that a malfunction of the prismax caused or contributed to the serious event of excessive fluid removal requiring medical intervention and subsequent death.The event was caused by a device use error when entering the treatment parameters.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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