Catalog Number 10226 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 09/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that a patient had a therapeutic plasma exchange (tpe) procedure on (b)(6) 2021.The procedure used 1000ml fresh frozen plasma+1000ml common plasma.Per the customer, the patient appeared pneumorrhagia, epistaxis and blood clotting function abnormal at (b)(6) 2021.The patient returned to normal after infused with 400ml fresh frozen plasma.On (b)(6) 2021, the operator used saline to replace ac due to the abnormal clotting after previous procedure, 1000ml fresh frozen plasma+1000ml common plasma.After 2 hours of the procedure, the inspection result of blood clotting function was normal.But after 7 hours of the procedure, the inspection result was abnormal again.The exchange set is not available for return because it was discarded by the customer.Patient information and outcome are unknown at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf associated with this complaint show very high inlet:ac ratios for the procedures.However, according to the complaint the concentration of the ac used differentiates from the standard concentration.Review of the images does not show any clumping or any signs of issues during the procedure.The optia system appears safe to use and operated as intended.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that a patient had a therapeutic plasma exchange (tpe) procedure on (b)(6) 2021.The procedure used 1000ml fresh frozen plasma+1000ml common plasma.Per the customer, the patient appeared pneumorrhagia, epistaxis and blood clotting function abnormal at (b)(6) 2021.The patient returned to normal after infused with 400ml fresh frozen plasma.On (b)(6) 2021, the operator used saline to replace ac due to the abnormal clotting after previous procedure, 1000ml fresh frozen plasma+1000ml common plasma.After 2 hours of the procedure, the inspection result of blood clotting function was normal.But after 7 hours of the procedure, the inspection result was abnormal again.The exchange set is not available for return because it was discarded by the customer.Patient information and outcome are unknown at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Event Description
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The customer reported that a patient had a therapeutic plasma exchange (tpe) procedure on (b)(6) 2021.The procedure used 1000ml fresh frozen plasma+1000ml common plasma.Per the customer, the patient appeared pneumorrhagia, epistaxis and blood clotting function abnormal at (b)(6) 2021.The patient returned to normal after infused with 400ml fresh frozen plasma.On (b)(6) 2021, the operator used saline to replace ac due to the abnormal clotting after previous procedure, 1000ml fresh frozen plasma+1000ml common plasma.After 2 hours of the procedure, the inspection result of blood clotting function was normal.But after 7 hours of the procedure, the inspection result was abnormal again.The exchange set is not available for return because it was discarded by the customer.Patient information and outcome are unknown at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.3.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf associated with this complaint show very high inlet:ac ratios for the procedures.However, according to the complaint the concentration of the ac used differentiates from the standard concentration.Review of the images does not show any clumping or any signs of issues during the procedure.The optia system appears safe to use and operated as intended.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that a patient had a therapeutic plasma exchange (tpe) procedure on (b)(6) 2021.The procedure used 1000ml fresh frozen plasma+1000ml common plasma.Per the customer, the patient appeared pneumorrhagia, epistaxis and blood clotting function abnormal at (b)(6) 2021.The patient returned to normal after infused with 400ml fresh frozen plasma.On (b)(6) 2021, the operator used saline to replace ac due to the abnormal clotting after previous procedure, 1000ml fresh frozen plasma+1000ml common plasma.After 2 hours of the procedure, the inspection result of blood clotting function was normal.But after 7 hours of the procedure, the inspection result was abnormal again.The exchange set is not available for return because it was discarded by the customer.Patient identifier was not provided by the customer.The customer confirmed the coagulation results returned to normal ranges.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Manufacturer Narrative
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This report is being filed to provide additional information in a.2, a.3, a.4, b.5, b.6, e.1, h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf associated with this complaint show very high inlet:ac ratios for the procedures.However, according to the complaint the concentration of the ac used differentiates from the standard concentration.Review of the images does not show any clumping or any signs of issues during the procedure.The optia system appears safe to use and operated as intended.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to therapeutic plasma exchange as management of complicated systemic lupus erythematosus (sle) and other autoimmune diseases (aguirre-valencia, et al, hindawi volume 2019, article id 5350960, p.2): the most prevalent diagnosis was sle (n=40, 60.61%).In these patients, the main indication of tpe was diffuse alveolar hemorrhage (dah; n=11, 27.5%) and neuropsychiatric involvement (n=9, 22.5%), including patients with central, peripheral, and psychiatric compromise.The other indications in patients with sle were thrombotic microangiopathy (n=5, 12.5%), catastrophic aps (n=4, 10%), lupus nephritis (n=4, 10%; all had type iv diffuse proliferative nephritis), gastrointestinal involvement (lupus pseudoobstruction; n=1, 2.5%), severe sle (polyserositis and joint swelling; n=1, 2.5%), severe resistance to type b insulin (n=1, 2.5%), evans syndrome (n=1, 2.5%), and kidney allograft rejection (n=1, 2.5%).A disposable lot history search indicated there were no other reported occurrences of adverse reactions on this lot worldwide.Root cause: a root cause assessment was performed for the adverse reactions experienced by both patients.Based on the information provided by the customer, the dlog analysis, and the scientific journal by aguirre-valencia, et al, the adverse reactions experienced by both patients are frequent pathologies associated with systemic lupus erythematosus.
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Search Alerts/Recalls
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