MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number 10226

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient had a therapeutic plasma exchange (tpe) procedure on (b)(6) 2021, the procedure was completed using the ac concentration of 8g/200ml.The patient had a second tpe procedure on (b)(6) 2021 using 1000ml fresh frozen plasma+1000ml common plasma.The patient appeared gastrorrhagia at (b)(6) 2021 noon.The inspection result of blood clotting function was abnormal.The patients clotting returned to normal after the infusion of 400ml fresh frozen plasma.On (b)(6) 2021, the operator used saline to replace ac due to the abnormal after previous procedure as well as 1000ml fresh frozen plasma+1000ml common plasma.After 2 hours of completing the procedure, the inspection result of blood clotting function was normal.But after 7 hours of the procedure, the inspection result was abnormal again.Patient information and outcome are unknown at this time.The exchange set is not available for return because it was discarded by the customer.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.

Event Description

The customer reported that a patient had a therapeutic plasma exchange (tpe) procedure on (b)(6) 2021, the procedure was completed using the ac concentration of 8g/200ml.The patient had a second tpe procedure on (b)(6) 2021 using 1000ml fresh frozen plasma+1000ml common plasma.The patient appeared gastrorrhagia at (b)(6) 2021 noon.The inspection result of blood clotting function was abnormal.The patients clotting returned to normal after the infusion of 400ml fresh frozen plasma.On (b)(6) 2021, the operator used saline to replace ac due to the abnormal after previous procedure as well as 1000ml fresh frozen plasma+1000ml common plasma.After 2 hours of completing the procedure, the inspection result of blood clotting function was normal.But after 7 hours of the procedure, the inspection result was abnormal again.Patient information and outcome are unknown at this time.The exchange set is not available for return because it was discarded by the customer.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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.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.

Event Description

The customer reported that a patient had a therapeutic plasma exchange (tpe) procedure on (b)(6) 2021 the procedure was completed using the ac concentration of 8g/200ml.The patient had a second tpe procedure on (b)(6) 2021 using 1000ml fresh frozen plasma+1000ml common plasma.The patient appeared gastrorrhagia at (b)(6) 2021 noon.The inspection result of blood clotting function was abnormal.The patients clotting returned to normal after the infusion of 400ml fresh frozen plasma.On (b)(6) 2021, the operator used saline to replace ac due to the abnormal after previous procedure as well as 1000ml fresh frozen plasma+1000ml common plasma.After 2 hours of completing the procedure, the inspection result of blood clotting function was normal.But after 7 hours of the procedure, the inspection result was abnormal again.Patient information and outcome are unknown at this time.The exchange set is not available for return because it was discarded by the customer.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.

Manufacturer Narrative

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.

Event Description

The customer reported that a patient had a therapeutic plasma exchange (tpe) procedure on (b)(6) 2021, the procedure was completed using the ac concentration of 8g/200ml.The patient had a second tpe procedure on (b)(6) 2021 using 1000ml fresh frozen plasma+1000ml common plasma.The patient appeared gastrorrhagia at (b)(6) 2021 noon.The inspection result of blood clotting function was abnormal.The patients clotting returned to normal after the infusion of 400ml fresh frozen plasma.On (b)(6) 2021, the operator used saline to replace ac due to the abnormal after previous procedure as well as 1000ml fresh frozen plasma+1000ml common plasma.After 2 hours of completing 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 customer did not specify any medical intervention for this patient after the abnormal coagulation results.The customer declined to provide patient identifier.Patient¿s gender and weight were obtained from the run data file (rdf).The exchange set is not available for return because it was discarded by the customer.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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 12636631
• MDR Text Key: 281007700
• Report Number: 1722028-2021-00323
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: 10226
• Device Lot Number: 2104073130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/15/2021; 01/11/2022; 04/07/2022
• Supplement Dates FDA Received: 11/08/2021; 01/14/2022; 04/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 50 KG