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

Catalog Number 10220

Device Problems Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Seizures (2063)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time investigation: the majority of procedures performed were therapeutic plasma exchange (tpe); 15% of total procedures were performed in tandem with another extracorporeal support system (ecmo, cardiopulmonary bypass, crrt) as tpe for solid organ transplantation rejection.Ta was performed using one of three systems: cobe spectra (terumobct (b)(4)), spectra optia (terumobct, (b)(4)) or therakos cellex.Hypotension was defined as a blood pressure change more than two standard deviations below average for patient age.Patients with pre-existing hypotension were excluded.Hypocalcemia was defined as low serum ionized calcium (<4.4 mg/dl) associated with symptoms (numbness, tingling, muscle spasm, nausea, vomiting).In patients unable to verbalize symptoms (e.G., younger children, those with altered mental status, intubated or sedated) point of care venous ionized calcium levels were monitored every 15 minutes for tpe and rbc exchange procedures.Procedure failure was defined as inability to complete the ordered ta procedure.Procedure related mortality rate was defined as patient death as direct result of the ta procedure within a 24 hour period.Case mortality was defined by patient death prior to discharge home from the hospital admission for which they received the ta procedure.Anticoagulation therapies utilized depended on the ta procedure and the presence of other extracorporeal treatment in tandem.If patients were undergoing ecp or tandem extracorporeal support (i.E., ecmo or cardiopulmonary bypass), continuous systemic heparin infusion provided anticoagulation.If systemic heparin infusion was used for anticoagulation, 0.9% normal saline was used as the "prescribed anticoagulant," instead of citrate dextrose (acd-a) and run at a 50:1 ratio to allow the spectra optia to perform its therapy.The remaining patients used acd-a for circuit anticoagulation.Calcium infusions of either calcium chloride or calcium gluconate were run throughout the procedures at a preprescribed rate per institution policy.Vascular access was obtained in the safest and least invasive way possible to maintain flows necessary for treatment and was dependent on patient size.Ta is known for common minor adverse events including hypotension and hypocalcemia.In a pediatric population, these complications can be even higher, with up to 55% of procedures having an adverse event.The authors concluded that the low number (1.6%) of minor adverse events for ta may be due to adherence to an institutional based protocol to mitigate citrate toxicity, which use slow citrate infusion increases and close calcium monitoring upon initiation of therapy.Their review demonstrated severe adverse events including seizure, pneumothorax, hemorrhagic stroke, and cardiac arrest in 3.4% of our population and case mortality of 4%.Mortality data for those receiving ecmo in the pediatric population ranges from 16 to 45% across the international registry of ecmo support.11 severe adverse events, including stroke, can occur in up to 12% of pediatric ecmo populations.Other common adverse events for ta including hypotension and anaphylaxis reactions were mitigated through embedded protocol orders employed at our institution.9 automated electronic alerts were built into the hospital standardized order sets and alerted providers of any patient receiving medications, which could induce hypotension (e.G., angiotensin-converting enzymes inhibitors).All patients had automatic orders to remain in bed at least 30 min post procedure, to reduce procedure related syncope.Automatic orders for heparin locks decreased the risk of clot and malfunction of lumens having intermittent access for apheresis procedures.Lastly, anaphylaxis kits were ordered to bedside during apheresis procedures to treat procedure complications from transfusion reactions.Citation: sirignano, r. m., paden, m. l., fasano, r., & meyer, e. k.(2017).Epidemiology of therapeutic apheresis with a multidisciplinary approach at a high volume pediatric center.Journal of clinical apheresis, 33(3), 297-302.Https://doi.Org/10.1002/jca.21604 investigation is in process.A follow-up report will be provided.

Event Description

A terumo bct employee identified an article by sirignano et al., "epidemiology of therapeutic apheresis with a multidisciplinary approach at a high volume pediatric center", which describes a series of therapeutic apheresis procedures at a high volume pediatric center.The authors conducted a retrospective chart review of patients receiving therapeutic apheresis (ta) from january 1, 2012 through october 31, 2015.Data collected included demographics, american society of apheresis (asfa) indication, complications, and mortality.Over 46 months, 1198 procedures were conducted on 289 patients ranging in age from 5 months to 21 years with weights ranging from 4.76 to 170.3 kg (16 procedures in patients <10 kg).The procedures were 86% therapeutic plasmaexchange, 10% red blood cell (rbc) exchange, 4% extracorporeal photopheresis (ecp), and 5 leukocytapheresis procedures (lcp).Referral and initiation of ta occurred in a variety of care settings; 37% of the patients were critically ill in an intensive care unit (table 1); 23% of patients who were critically ill upon initiation of ta were in the cardiac intensive care unit and the remaining 83% were in the pediatric intensive care unit.Demographics characteristic description total patients 298 male 151 female 147 ta procedure modality total procedures (#) (% of total) tpe 1025 (85.6) rbc exchange 122 (10) ecp 46 (4) lcp 5 (0.4) information regarding procedure related complications, procedure failures, procedure-related mortality, and case mortality was collected.Procedure complications were defined as any clinical issue, which occurred to the patient as a direct result of ta within a 24 hour period following the procedure.These complications included hypotension and hypocalcemia.Of the 1198 procedures, 21 (1.8%) experienced equipment related complications, and an additional 29 (2.4%) experienced patient related complications.One pump malfunction was due to inability to achieve adequate blood flow for the ecmo pump and an additional internal jugular cephalad directed cannula was added to help achieve prescribed flow.Once prescribed extracorporeal support flow was maintained, the tpe could be performed in parallel circuit on the spectra optia machine.Another pump malfunction was due to a faulty air-in-line sensor, which contributed to tpe being aborted on the spectra optia.The equipment related complications of low flow states, clots, and air in return accounted for 14 of the 15 procedures, which were unable to be completed, resulting in a 1% procedure failure rate.The two patients who sustained a cardiac arrest were both orthotopic heart transplant recipients.The events occurred during induction of anesthesia prior to placement on cardiopulmonary bypass, and patients were successfully resuscitated.Plasmapheresis was paused until after patient stabilization, but ultimately one of the two procedures was unable to be completed.Two patients who sustained intracranial hemorrhage presented with seizure symptoms duringta.One patient presented with seizure and stroke like symptoms, and was ultimately identified to have cns vasculitis, for which therapy was halted upon definitive diagnosis.Three patients (1%) had a pneumothorax during central venous access placement, which was treated through thoracentesis and chest tube placement.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in e.1.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: since this was a retrospective study 46 months, between 2012 and 2015, of 1198 ta procedures, the lot numbers are unknown; therefore, lot numbers are unknown and dhr searches could not be conducted for the reported incidents.All lots must meet acceptance criteria for release.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Citrate related reactions occur with a frequency of 1.2% transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures (0.2%) if hypocalcemia escalates and is not corrected.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.Investigation is in process.A follow up report will be provided.

Event Description

Due to guidelines for retrospective chart reviews whereby recorded data must not identify or be linkable to subjects, a request for patient information is not feasible.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: per internal medical review and assessment, both spectra optia and cobe spectra performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any reported user errors that contributed to or caused these adverse events.Two patients sustained intracranial hemorrhage presented with seizure symptoms during ta.The author did not attribute device malfunction or operator errors to both adverse events.According to the journal, anticoagulation therapies utilized depended on the ta procedure and the presence of other extracorporeal treatment in tandem.If patients were undergoing ecp or tandem extracorporeal support (i.E., ecmo or cardiopulmonary bypass), continuous systemic heparin infusion provided anticoagulation.If systemic heparin infusion was used for anticoagulation, 0.9% normal saline was used as the "prescribed anticoagulant," instead of citrate dextrose (acd-a) and run at a 50:1 ratio to allow the spectra optia to perform its therapy.One patient presented with seizure and stroke like symptoms, and was ultimately identified to have cns vasculitis, for which therapy was halted upon definitive diagnosis.This condition can block oxygen to the brain and ultimately, lead to strokes.Therefore, there is no failure mode or associated risk that can be evaluated for spectra optia.Two patients sustained intracranial hemorrhage presented with seizure symptoms during ta.The author did not attribute device malfunction or operator errors to both adverse events.Therefore, there is no failure mode or associated risk that can be evaluated for spectra optia.According to 'anticoagulation techniques in apheresis: from heparin to citrate and beyond': all heparins exert their primary anticoagulant effect by binding antithrombin (at) and altering its conformation to produce rapid inactivation of clotting factors, particularly thrombin and factor xa.Thus, the major complication of ufh therapy is bleeding (major bleeding 0-7%, fatal bleeding 0-3%).Hemorrhagic episodes are correlated with the intensity of anticoagulation, concomitant use of anti-platelet therapy, gender (f>m), comorbidities such as recent surgical or interventional procedures, and coexisting hemostatic defects.In patients receiving heparin therapy for continuous renal replacement, bleeding risk was shown to be increased by 50% for every 10 second rise in the aptt.Other complications include heparin-induced thrombocytopenia (hit) 1-5%,60 and osteoporosis (2-3% risk of vertebral fracture with >1 month treatment).Root cause: one patient presented with seizure and stroke like symptoms, and was ultimately identified to have cns vasculitis, for which therapy was halted upon definitive diagnosis.This condition can block oxygen to the brain and ultimately, lead to strokes.Two patients sustained intracranial hemorrhage presented with seizure symptoms during ta.The author did not attribute device malfunction or operator errors to both adverse events.A definitive root cause could not be determined.Possible causes include but are not limited to: ¿ patients' underlying disease state ¿ effects of systemic heparinization a definitive root cause for the hypocalcemia reactions could not be determined.Possible causes include but are not limited to ac m anagement during the procedure, the patient's medical condition, and/or patient sensitivity to anticoagulant.A definitive root cause for the hypotensive reactions could not be determined.Possible causes vasovagal reactions include but are not limited to the patient's medical condition and/or patient sensitivity to the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9872536
• MDR Text Key: 190370281
• Report Number: 1722028-2020-00132
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention