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

Model Number 10220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Blood Loss (2597)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: available treatments were continued between tpe sessions.Cholestyramine was given to 13 patients.12 patients were given ptu 16 patients were treated with prednisone.No complications e.G., hypotension and catheter related complications (hematoma, infection, or thrombosis) were noted either during or after the tpe sessions.4 patients showed a significant decrease (>3g/dl) in hemoglobin but none of them required a transfusion.Definitive treatments were performed for 17 patients after at least 1 tpe session.16 thyroidectomies 1 radioiodine treatment which lead to hyperthyroidism without any other side effects.Regarding surgical procedures, heavy perioperative bleeding was reported by the surgeon for 3 patients with gd, but no transfusion was necessary.Postoperatively ¿ hypocalcemia was detected in 3 patients.Transitory dysphonia was observed in 1 patient.In patients, tpe session associated with medication improved their clinical state and a simple clinical follow-up was possible without any radical treatment.Article citation: saie, c., et.Al.2020.Therapeutic plasma exchange in refractory hyperthyroidism.European thyroid journal.Doi: 10.1159/000507019.Investigation is in process.A follow-up report will be provided.

Event Description

The article, 'therapeutic plasma exchange in refractory hyperthyroidism' (saie 2020) describes a study on therapeutic plasma exchange (tpe) procedures performed on hyperthyroid patients.It describes a series of 22 patients with hyperthyroidism who underwent 91 tpe procedures between 2007 and the first semester of 2017.All tpe procedures were performed with spectra optia.There were 10 men (44%) and 12 women (56%) with a median age of 47 years (range 16¿85 years).Graves¿ disease (gd) was diagnosed in 13 patients (59%), 7 patients (32%) had amiodarone-induced thyrotoxicosis (ait), and 1 patient had a toxic goiter.The remaining case was a pregnant woman in whom the cause of thyrotoxicosis was an activating mutation of the thyroid-stimulating hormone (tsh) receptor (nonautoimmune thyrotoxicosis).Per the article, a significant decrease in hemoglobin (>3 g/dl) was observed in four patients after tpe.Three patients experienced heavy perioperative bleeding.Transfusions were not required for these patients, though any action taken to treat them is unknown.Of the 22 patients, 16 had a total thyroidectomy and one patient was treated with radioactive iodine.The remaining 4 patients were followed up without any radical treatment.Specific details, including patient information for the adverse events, were not included in the article, therefore this report is being provided as a summary of the events.The disposable set is not available for return because it was discarded by the customer.

Event Description

This was a retrospective clinical study to evaluate the use of therapeutic plasma exchange (tpe) in hyperthyroid patients between 2007 and 2017, involving twenty-two patients.There were 10 men (44%) and 12 women (56%) with a median age of 47 years (range 16¿85 years).A request for specific patient information is not feasible.

Manufacturer Narrative

Investigation: 4 patients showed a significant decrease (>3g/dl) in hemoglobin but none of them required a transfusion.According to therapeutic apheresis: a physician's handbook, with current centrifugal technology, reductions in platelet count are usually modest, and levels quickly return to baseline.In a severely thrombocytopenic patient, however, such a loss may mask the beginning of platelet recovery.Similarly, the small amount of red cells lost in the apheresis circuit may be more apparent in an anemic patient who has meager production capacity and who is receiving multiple procedures.Although generally well tolerated, the large-volume leukocytapheresis for stem cell collections in patients often results in a decline in hematocrit and platelet count, particularly because some red cells and platelets are incidentally removed with the stem cells.3 patients experienced heavy perioperative bleeding.Transfusions were not required though the action taken is unknown.According to therapeutic apheresis: a physician's handbook, if fibrinogen decreases a great deal below 100 mg/dl, some physicians will then increase the interval between procedures or will use plasma replacement during the last part of the procedure to avoid a potential bleeding diathesis.18 fresh frozen plasma (ffp) is the preferred source of fibrinogen, and it supplies other coagulation factors as well.Ffp is seldom required, though, if tpe is performed at intervals of 72 hours or greater.Hemorrhage is rarely reported in patients undergoing a tpe series without plasma replacement if there is no underlying predisposition to bleeding.Dhr details: since this was a retrospective clinical study to evaluate the use of therapeutic plasma exchange (tpe) in hyperthyroid patients between 2007 and 2017, the lot numbers are unknown; therefore, a dhr search could not be conducted for the reported incident.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Based on the clinical and investigation findings, the spectra optia device 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.Per the article, " results: before tpe, all patients had severe hyperthyroidism, and antithyroid drugs were either contraindicated or not sufficiently effective to restore euthyroidism promptly.After all the tpes, free t4 (ft4) decreased significantly by 48% (p = 0.001) and ft3 by 52% (p = 0.0001).The median number of tpe sessions per patient was 4 (range: 1¿10).The first hormonal measurement was performed between 1 and 10 h after the tpe session, and it showed a 20% decrease in ft4 and ft3 from the pre-tpe level.Ft4 and ft3 levels were measured, on average, 2 days (range 0¿11 days) after all tpe sessions.Ft4 decreased significantly by 48% (p = 0.001) and ft3 by 52% (p = 0.001) (fig.1).Tpe failed to decrease thyroid hormone levels in 1 case (patient no.8) despite 3 sessions.Tpe restored ft3 to normal levels in 2 patients (9%) in an average time of 3 days.Ft4 levels were strictly normalized in 8 patients (36%) within an average of 6 days (range 1¿19 days).The normalization of both ft3 and ft4 was achieved in 1 patient.No complications, e.G., hypotension and catheterrelated complications (hematoma, infection, or thrombosis) were noted either during or after the tpe sessions.At the end of the iterative tpe sessions, no hypocalcemia was observed.The median decrease in hemoglobin was 1 g/dl; 4 patients showed a significant decrease (> 3 g/dl) but none of them required a transfusion." the goal of the study was to evaluate the use of therapeutic plasma exchange (tpe) in hyperthyroid patients and their outcome after tpe.Method: the authors retrospectively reviewed 22 patients who underwent tpe for refractory thyrotoxicosis in their institution: 13 with graves¿ disease (gd), 7 with amiodarone-induced thyrotoxicosis (ait), 1 with toxic goiter, and 1 pregnant patient with familial nonautoimmune thyrotoxicosis.Results: before tpe, all patients had severe hyperthyroidism, and antithyroid drugs were either contraindicated or not sufficiently effective to restore euthyroidism promptly.After all the tpes, free t4 (ft4) decreased significantly by 48% (p = 0.001) and ft3 by 52% (p = 0.0001).The median number of tpe sessions per patient was 4 (range: 1¿10).The first hormonal measurement was performed between 1 and 10 h after the tpe session, and it showed a 20% decrease in ft4 and ft3 from the pre-tpe level.Ft4 and ft3 levels were measured, on average, 2 days (range 0¿11 days) after all tpe sessions.Ft4 decreased significantly by 48% (p = 0.001) and ft3 by 52% (p = 0.001) (fig.1).Tpe failed to decrease thyroid hormone levels in 1 case (patient no.8) despite 3 sessions.Tpe restored ft3 to normal levels in 2 patients (9%) in an average time of 3 days.Ft4 levels were strictly normalized in 8 patients (36%) within an average of 6 days (range 1¿19 days).The normalization of both ft3 and ft4 was achieved in 1 patient.No complications, e.G., hypotension and catheterrelated complications (hematoma, infection, or thrombosis) were noted either during or after the tpe sessions.At the end of the iterative tpe sessions, no hypocalcemia was observed.The median decrease in hemoglobin was 1 g/dl; 4 patients showed a significant decrease (> 3 g/dl) but none of them required a transfusion.Tpe was found to be a good preparation for surgery in our study, as there were no surgical or anesthetic complications recorded even in patients with a history of heart disease.In a previous study, the reported surgical morbidity rate was 29% in patients operated on for ait without any tpe preparation [8].In our study, hypocalcemia was recorded in 3 patients (19%) after thyroidectomy, which corresponds to the reported incidence of transitory postoperative hypocalcemia in the literature [9, 10].Ozbey et al.[11] raised the awareness of the decrease in antithrombotic factors and thus the risk of perioperative bleeding in thyroid surgery after tpe.In 3 thyroidectomies after tpe for gd, surgeons recorded perioperative bleeding, but there were no transfusions or adverse anesthetic events.There were no complications during the 91 tpe sessions.Total thyroidectomy with no severe side effects was performed on 16/22 patients and 1 other patient was treated with radioactive iodine.One patient died from severe thyrotoxicosis during medical care.The remaining 4 patients were followed up without any radical treatment.For all 7 patients with ait, iterative tpe led to a significant clinical improvement, and amiodarone was continued for 1 patient.Available treatments were continued between tpe sessions (cholestyramine for 13 patients [60%] and glucocorticoids for 16 patients [73%]).Conclusion: tpe allowed a safe decrease of 50% in thyroid hormone levels, and it should be considered for refractory hyperthyroid patients when medical treatments are contraindicated or have failed to restore euthyroidism, irrespective of the etiology of the thyrotoxicosis.Root cause: a definitive root cause for the hemoglobin loss could not be determined.Possible causes may be due to: - processing large volume tbv - inaccurate entry of patient's hematocrit resulting in loss of red blood cells - dilution effect due to large volume of acda or acda/heparin infused - patient's underlying disease state according to the authors, the perioperative bleeding was related to a decrease in antithrombotic factors after tpe as a result of using 5% albumin as replacement fluid.A definitive root cause for the failure to decrease thyroid hormone levels could not be determined.Possible causes may be due to: - patient's underlying disease state - ineffective treatment.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10092184
• MDR Text Key: 196944120
• Report Number: 1722028-2020-00250
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

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 Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 06/17/2022; 07/20/2022
• Supplement Dates FDA Received: 06/24/2022; 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Other