ALUNG TECHNOLOGIES, INC. HEMOLUNG RAS; EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL
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Model Number HL-CR4-01-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/16/2019 |
Event Type
Injury
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Event Description
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Alung technologies, inc.Received a report that a patient experienced an abnormal lab result, partial thromboplastin time during hemolung therapy.No further information was given.
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Manufacturer Narrative
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Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).An adverse event occurred within patient therapy in which the patient experienced an abnormal lab result of partial thromboplastin time.The patient had an increase in their partial thromboplastic time to 139.0 with no baseline prior.The data log from therapy has been retrieved and reviewed by both clinical and software engineering staff.No abnormalities were noted within the co2 removal and blood flow graphs.Therapy was provided as intended.No capa was opened because of this event.Bleeding is a known potential complication associated with use of extracorporeal therapy.Review of the data log shows that therapy was provided as intended.Alung technologies, inc.Will continue to monitor any issues as they are reported.This mdr is being filed in response to a retrospective view of all alung technologies, inc.Complaints, which identified that the reporting decision for this complaint was not correct.This mdr is being filed retrospectively to correct the error in the reporting decision.
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