Model Number 5160-0000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hemolysis (1886); Thrombocytopenia (4431)
|
Event Type
Injury
|
Manufacturer Narrative
|
Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Cardiacassist inc.Manufactures the tandemlung oxygenator.The incident occurred in (b)(6).Based on the information currently available, a medical assessment was requested revealing that the reported hemolysis is not related to tandemlung oxygenator and that it is a risk associated to the procedure itself.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device in use.
|
|
Event Description
|
Livanova received report that during ecmo support of a covid-19 patient a dual tandemlung oxygenators setup was used and hemolysis associated with anemia requiring rbc transfusion was noticed on (b)(6) 2021.Due to significant hemolysis noted and thrombocytopenia, the flow was minimized maintaining adequate global perfusion.The patient has been off heparin infusion for roughly 24 hours and reportedly there is a plan to restart heparin infusion for or possible clots formation.
|
|
Manufacturer Narrative
|
Section b.1 and b.2 have been corrected and aligned to what reported in h.1 in the initial report.H.10: serial number of oxygenator was not provided and remains unknown.As stated in the initial report, as per medical assessment conducted on this event, the oxygenator is not possibly related to the reported hemolysis.Oxygenator may have contributed to clots formation.However, this is unlikely since the support was on a patient affected by covid-19 which was not subjected to anticoagulation therapy for 24 hours.Covid-19 disease can contribute/lead to clotting formation due to a higher incidence of coagulopathy and thrombosis.Covid-19 desease in combination with an inadequate anticoagulation therapy are the most likely causes of the reported clots.In conclusion, both hemolysis and clotting are not related to any oxygenator malfunction.
|
|
Event Description
|
See initial report.
|
|
Search Alerts/Recalls
|