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

Catalog Number	10220
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Hypersensitivity/Allergic reaction (1907); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article, "red blood cell exchange in children with sickle cell disease" by elenga, n., vantilcke, v., martin, e., cuadro, e., selles, p., & basset, t., the aim of the study was to assess the efficacy of red blood cell exchange (rbcx) using a spectra optia automated apheresis system in children with sickle cell disease (scd).Using automated rbcx to treat acute and chronic complications in 75 children with scd who had a median age of 10 years [7¿13], 649 rbcx sessions were analyzed.Peripheral venous access was limited in a number of the children, and thus a femoral double-lumen central venous catheter, and heparin locking with 500 units in each lumen of the catheter.To prevent complications, all patients had achieved a post-rce hb level of <30%.For chronic transfusion, with a post-rce hb level of approximately 10¿11 g/dl, a blood exchange volume of =32 ml/kg, and an interval between each rbcx procedure of =30 days, the residual hbs level was maintained below 30%.For acute transfusion, a post-exchange hb level =10 g/dl (p<0.001) and a total exchange volume =35 ml/kg (p=0.001) was the best way to reduce hbs to<30%.Auc was 0.84.Results showed that erythrocytapheresis were useful and safe for children with scd.However, three episodes of deep vein thrombosis requiring heparin treatment occurred in three patients.These thromboses occurred in children aged 11, 12, and 13 years, who maintained the catheter for more than 12 hrs after the end of the erythrocytapheresis procedure.In two cases of unilateral thrombosis of the femoropopliteal vein, the evolution was rapidly favorable after removal of the catheter and anticoagulant treatment.The third patient presented a bilateral iliofemoral-popliteal vein thrombosis, complicated by a right pulmonary embolism, despite catheter removal.Additionally, between 2012 and 2019, 19 children (13 boys and 6 girls), with a median age of 8 [7¿10] years were placed on chronic transfusion for stroke prevention.Of these, 17 had homozygous scd and two had sickle ¿0-thalassaemia.Nine had a history of stroke and ten an abnormal transcranial doppler (tcd) velocity (and normal magnetic resonance imaging (mri) brain scan).Side effects and complications included iron overload, non-haemolytic transfusion reaction, thromboembolic complications, allergic reaction, acute haemolytic transfusion reaction, presence of blood clots in the central catheter.One patient developed red blood cell alloantibodies.Of the 17 patients, 4 required iron chelation.For 24% of the patients, the hbs level was below 30%.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.The set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: lot number, manufacture and expiry date are not available at this time.Investigation is still in process, a follow-up report will be provided.Elenga, n., vantilcke, v., martin, e., cuadro, e., selles, p., & basset, t.(2021).Red blood cell exchange in children with sickle cell disease.International journal of hematology, 115(1), 107¿113.Https://doi.Org/10.1007/s12185-021-03221-8.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: lot number, manufacture and expiry date are not available at this time.  it has been determined that the event submitted on this report is a duplicate of the event submitted on report 1722028-2021-00340.Elenga, n., vantilcke, v., martin, e., cuadro, e., selles, p., & basset, t.(2021).Red blood cell exchange in children with sickle cell disease.International journal of hematology, 115(1), 107¿113.Https://doi.Org/10.1007/s12185-021-03221-8.
Event or Problem Description
Per journal article, "red blood cell exchange in children with sickle cell disease" by elenga, n., vantilcke, v., martin, e., cuadro, e., selles, p., & basset, t., the aim of the study was to assess the efficacy of red blood cell exchange (rbcx) using a spectra optia automated apheresis system in children with sickle cell disease (scd).Using automated rbcx to treat acute and chronic complications in 75 children with scd who had a median age of 10 years [7¿13], 649 rbcx sessions were analyzed.Peripheral venous access was limited in a number of the children, and thus a femoral double-lumen central venous catheter, and heparin locking with 500 units in each lumen of the catheter.To prevent complications, all patients had achieved a post-rce hb level of <30%.For chronic transfusion, with a post-rce hb level of approximately 10¿11 g/dl, a blood exchange volume of =32 ml/kg, and an interval between each rbcx procedure of =30 days, the residual hbs level was maintained below 30%.For acute transfusion, a post-exchange hb level =10 g/dl (p<0.001) and a total exchange volume =35 ml/kg (p=0.001) was the best way to reduce hbs to<30%.Auc was 0.84.Results showed that erythrocytapheresis were useful and safe for children with scd.However, three episodes of deep vein thrombosis requiring heparin treatment occurred in three patients.These thromboses occurred in children aged 11, 12, and 13 years, who maintained the catheter for more than 12 hrs after the end of the erythrocytapheresis procedure.In two cases of unilateral thrombosis of the femoropopliteal vein, the evolution was rapidly favorable after removal of the catheter and anticoagulant treatment.The third patient presented a bilateral iliofemoral-popliteal vein thrombosis, complicated by a right pulmonary embolism, despite catheter removal.Additionally, between 2012 and 2019, 19 children (13 boys and 6 girls), with a median age of 8 [7¿10] years were placed on chronic transfusion for stroke prevention.Of these, 17 had homozygous scd and two had sickle ¿0-thalassaemia.Nine had a history of stroke and ten an abnormal transcranial doppler (tcd) velocity (and normal magnetic resonance imaging (mri) brain scan).Side effects and complications included iron overload, non-haemolytic transfusion reaction, thromboembolic complications, allergic reaction, acute haemolytic transfusion reaction, presence of blood clots in the central catheter.One patient developed red blood cell alloantibodies.Of the 17 patients, 4 required iron chelation.For 24% of the patients, the hbs level was below 30%.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.The set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA APHERESIS SYSTEM
• Common Device Name: 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: 20052196
• Report Number: 1722028-2024-00355
• Device Sequence Number: 15483173
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (Y/N): N
• Initial Reporter Country: FG
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown