Catalog Number 115821 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemolysis (1886)
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Event Date 10/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Should additional information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a patient being treated with an ak 96 dialysis machine, a polyflux 210h dialyzer and bl14 novaline blood lines presented to the emergency department later in the day after discharge to home from therapy.The patient was hospitalized due to suspected hemolysis.The patient is reported to have been hospitalized for three days and was discharged.At the time of this report, the patient was reported to be doing fine with no further ailments relating to the incident.No additional information is available.
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Manufacturer Narrative
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Additional information h6 and h0.The sample was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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