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

Catalog Number 10220

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Paralysis (1997); Thrombosis (2100)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: tsitsikas, da, et al.2016.Safety, tolerability, and outcomes of regular automated red cell exchange transfusion in the management of sickle cell disease.Journal of clinical apheresis.2016; 31:545¿550.Investigation is in process.A follow-up report will be provided.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.

Event Description

The article, 'safety, tolerability, and outcomes of regular automated red cell exchange transfusion in the management of sickle cell disease' (tsitsikas 2016) describes 50 patients who underwent 504 regular automated red blood cell exchange (rbcx) procedures with spectra optia.Twenty-seven patients were male and 23 female with a mean age of 38 (19¿58).During the study, the mean pre-transfusion platelet (plt) count was 352 x 10^9/l (65¿765) and the mean post-transfusion plt count was 106 x 10^9/l (19¿593) representing a 70% reduction.Of note, the post- transfusion plt count was <100 x 10^9/l and <50 x 109/l (described as severe thrombocytopenia) on 49% (247 procedures) and 6% of procedures (30 procedures), respectively, three of the 50 (6%) patients developed a total of four new antibodies while on regular automated rbcx procedures representing a rate of formation of new antibodies of 0.065/100 units of red cells.Other adverse events described are: vasovagal symptoms: occurred in 17 (35%) patients with one patient experiencing up to eight such episodes.None of these episodes was associated with documented hypocalcaemia.For the majority of patients experiencing more than one such episode, reducing the rate of the anticoagulant infusion for subsequent procedures resolved or improved the problem.Transient paresthesia: occurred in 8 (16%) patients.Bleeding from femoral line exit site: 7 episodes involving five (10%) patients resulting in one hospital admission but the use of blood transfusion was not necessary.None of those patients had plt <50 x 10^9/l at the time.Retention of line guide wire: 1 patient (2%).Formation of pelvic hematoma: 1 patient (2%).Line-related deep vein thrombosis: 1 patient (2%), patient has protein s deficiency specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown that this time if medical intervention was required for these events.The disposable set is not available for return because it was discarded by the customer.

Event Description

Twenty-seven patients were male and 23 female with a mean age of 38 (range 19¿58).This was a retrospective study between june 2011 and december 2014 to assess the efficacy of regular automated red cell exchange transfusion in the management of sickle cell disease.A request for specific patient information is not feasible.

Manufacturer Narrative

This report is being filed to provide additional information in b5 and h10.Investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.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.Transient paresthesia occurred in 8 (16%) patients.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is ususally well tolerated.Symptoms often show as parasethesia (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 if hypocalcemia escalates and is not corrected.Platelet loss was identified in 6% of procedures (30 procedures) with post-transfusion plt count of <50 x 109/l platelet count considered as "severe thrombocytopenia".Dhr details: since this was a retrospective study between june 2011 and december 2014, the lot numbers are unknown; therefore, dhr searches could not be conducted for the reported incidents.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10.Investigation: 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.According to 2017 aaab circular, a reaction of the patients¿ immune system as a result of the treatment in three of the 50 (6%) patients who developed a total of four new antibodies while on regular automated rbcx procedures representing a rate of formation of new antibodies of 0.065/100 units of red cells.Alloimmunization to antigens of red cells, white cells, platelets, or plasma proteins may occur unpredictably after transfusion.Blood components may contain certain immunizing substances other than those indicated on the label.For example, platelet components may also contain red cells and white cells.Primary immunization does not become apparent until days or weeks after the immunizing event, and does not usually cause symptoms or physiologic changes.If components that express the relevant antigen are subsequently transfused, there may be accelerate removal of cellular elements from the circulation and/or systemic symptoms.Clinically significant antibodies to red cell antigens will ordinarily be detected by pretransfusion testing.Alloimmunization to antigens of white cells, platelets, or plasma proteins can be detected only by specialized testing.Bleeding from femoral line exit site: 7 episodes involving five (10%) patients resulting in one hospital admission but the use of blood transfusion was not necessary.None of those patients had plt <50 x 109/l at the time.Formation of pelvic hematoma: 1 patient (2%).According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Adverse effects related to vascular access are a frequent concern.Hematoma, venous sclerosis and thrombosis can complicate percutaneous needle puncture.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.According to therapeutic apheresis: a physician's handbook, adverse effects related to vascular access are a frequent concern.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.During a dressing change, the site should be cleaned and observed for signs of infection such as redness, swelling, drainage, and foul odor.If an infection is suspected, cvc removal should be considered, and the patient should be treated for infection as appropriate.Root cause: a definitive root cause for patient deaths could not be determined but is likely related to pre-existing disease state.A definitive root cause for patient reactions could not be determined.Possible causes for the alleged vasovagal reactions include but are not limited to patient disease state and/or patient sensitivity to the procedure.

• 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: 10422285
• MDR Text Key: 210185734
• Report Number: 1722028-2020-00396
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/21/2022
• 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