MAUDE Adverse Event Report: TERUMO BCT COBE SEPCTRA; COBE SPECTRA RBCX SET

Catalog Number 70700

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Urticaria (2278)

Event Date 01/24/2022

Event Type  Injury  

Event Description

According to the journal article "effectiveness of lymphoplasmapheresis compared with therapeutic plasma exchange for thrombotic thrombocytopenic purpura: a retrospective evaluation" by zang et al 2022 the study aimed to compare lymphoplasmapheresis (lpe), an innovative treatment for ttp based on plasma exchange, with tpe in ttp treatment.This retrospective study included patients with ttp treated at xiang-ya hospital in china during 2009-2018.All patients with microangiopathic hemolysis and thrombocytopenia who received either lpe or tpe were included.Cobe spectra was used for lpe.Lpe was performed with a white cell channel installed.Tpe was performed without a terumo bct device identified.Mild allergic reactions were the most common treatment-related adverse events in both groups, representing >70% of all adverse events.Several patients had urticaria on the face or breast, accompanied by skin itch.These symptoms disappeared after receiving corticosteroids or immunosuppressive agents.As shown in table 3 from the article, the numbers of urticaria and hypocalcemia events were not significantly different between the two groups (p>0.05).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 disposables sets are not available for return because they were discarded by the customer.

Manufacturer Narrative

Lot number, manufacture date and expiry date are not available.Investigation: per the article " forty-five patients were included in the study; 18 received tpe and 27 lpe.There were no significant differences in sex, etiology of ttp, initial platelet count, schistocyte, ldh, and bilirubin between the two groups.At the time of discharge, patients treated with tpe required more treatment sessions (4.5 vs.2, p=0.04) and higher plasma volume (7300 vs.3100 ml, p=0.01) than patients treated with lpe.The proportions of remission (p=0.197) and relapse (p=0.257) were not significantly different between the two groups.The time to remission from admission (p=0.75) and the time to remission from first therapy (p=0.53) were also not significantly different between the two groups.Conclusion: compared with tpe, lpe reduced the number of treatment sessions and plasma volume needed to treat ttp.Therefore, we propose that lpe might be a suitable treatment for ttp." citation: zhimin zhang, xi yuan, yuanjun jiang, ning li & bijuan li (2022) effectiveness of lymphoplasmapheresis compared with therapeutic plasma exchange for thrombotic thrombocytopenic purpura: a retrospective evaluation, hematology, 27:1, 167-172, doi: 10.1080/16078454.2021.2015842 investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

Investigation: thrombotic thrombocytopenic purpura (ttp) is an acute life-threatening disease usually treated with therapeutic plasma exchange (tpe), but some patients are refractory to tpe.The study aimed to compare lymphoplasmapheresis (lpe), an innovative treatment for ttp based on plasma exchange, with tpe in ttp treatment.This retrospective study included patients with ttp treated at (b)(6) hospital in china during 2009-2018.All patients with microangiopathic hemolysis and thrombocytopenia who received either lpe or tpe were included.The treatment outcomes were the number of sessions, volume of plasma, time in hospital, hospital costs, and rates of remission and relapse.All patients attended the hospital for follow-up.Lymphoplasmapheresis (lpe) is an innovative treatment based on plasma exchange.This process uses a blood cell separator to remove lymphocytes and mononuclear cells.Furthermore, hemolyzed red blood cells (rbcs), vwf, and vwf-multimers, close to the lymphocytes and mononuclear cells, can also be removed.An apheresis instrument (cobe spectra, terumo bct, (b)(6) usa) was for lpe.Lpe was performed with a white cell channel installed.The lymphoid cells were collected using density gradient centrifugation and photoelectricity technology in a manual program.Then, the feedback channel of patients¿ autologous plasma was clipped to fill the collection bag.Along with peripheral blood mononuclear cells (pbmcs), the lymphocytes were removed, while fresh frozen plasma was injected from the clamp at the top left of the heparin cap.It was reinfused to the patient¿s body after the confluence of the patient¿s red blood cells.Approximately 70%-80% of total blood volume was exchanged during each procedure.The volume was replaced with frozen plasma or plasma without cryoprecipitate.Lpe was stopped when platelets were >100×109/l for a minimum of 2 days.Tpe was performed using standard procedures until complete remission, defined as a platelet count above 100×109/l for a minimum of 2 days.Per the article " forty-five patients were included in the study; 18 received tpe and 27 lpe.There were no significant differences in sex, etiology of ttp, initial platelet count, schistocyte, ldh, and bilirubin between the two groups.At the time of discharge, patients treated with tpe required more treatment sessions (4.5 vs.2, p=0.04) and higher plasma volume (7300 vs.3100 ml, p=0.01) than patients treated with lpe.The proportions of remission (p=0.197) and relapse (p=0.257) were not significantly different between the two groups.The time to remission from admission (p=0.75) and the time to remission from first therapy (p=0.53) were also not significantly different between the two groups.Conclusion: compared with tpe, lpe reduced the number of treatment sessions and plasma volume needed to treat ttp.Therefore, we propose that lpe might be a suitable treatment for ttp." "an apheresis instrument (cobe spectra, terumo bct, (b)(6) usa) was for lpe.Lpe was performed with a white cell channel installed.The lymphoid cells were collected using density gradient centrifugation and photoelectricity technology in a manual program.Then, the feedback channel of patients¿ autologous plasma was clipped to fill the collection bag.Along with peripheral blood mononuclear cells (pbmcs), the lymphocytes were removed, while fresh frozen plasma was injected from the clamp at the top left of the heparin cap.It was reinfused to the patient¿s body after the confluence of the patient¿s red blood cells.Approximately 70%-80% of total blood volume was exchanged during each procedure.The volume was replaced with frozen plasma or plasma without cryoprecipitate.Lpe was stopped when platelets were >100×109/l for a minimum of 2 days." the product was not returned and therefore an evaluation could not be conducted.Since this was a journal publication to compare lymphoplasmapheresis (lpe), an innovative treatment for ttp based on plasma exchange, with tpe in ttp treatment, including patients with ttp treated at (b)(6) hospital in china during 2009-2018, it is not feasible to obtain the lot numbers and a disposable lot history search could not be conducted.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of (b)(4)%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.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 if hypocalcemia escalates and is not corrected citation: zhimin zhang, xi yuan, yuanjun jiang, ning li & bijuan li (2022) effectiveness of lymphoplasmapheresis compared with therapeutic plasma exchange for thrombotic thrombocytopenic purpura: a retrospective evaluation, hematology, 27:1, 167-172, doi: 10.1080/16078454.2021.2015842 root cause: possible causes for urticaria include but are not limited to one or a combination of the possible causes listed below: * hypersensitivity to the ethylene oxide used to sterilize the disposable set * hypersensitivity to the components inside the disposable set * allergic reaction to the replacement solution hypocalcemia occurs due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the patient's disease state, the rate of ac infusion, the citrate contents in the replacement fluid, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.

Event Description

According to the journal article "effectiveness of lymphoplasmapheresis compared with therapeutic plasma exchange for thrombotic thrombocytopenic purpura: a retrospective evaluation" by zang et al 2022 the study aimed to compare lymphoplasmapheresis (lpe), an innovative treatment for ttp based on plasma exchange, with tpe in ttp treatment.This retrospective study included patients with ttp treated at xiang-ya hospital in china during 2009-2018.All patients with microangiopathic hemolysis and thrombocytopenia who received either lpe or tpe were included.Cobe spectra was used for lpe.Lpe was performed with a white cell channel installed.Tpe was performed without a terumo bct device identified.Mild allergic reactions were the most common treatment-related adverse events in both groups, representing >70% of all adverse events.Several patients had urticaria on the face or breast, accompanied by skin itch.These symptoms disappeared after receiving corticosteroids or immunosuppressive agents.As shown in table 3 from the article, the numbers of urticaria and hypocalcemia events were not significantly different between the two groups (p>0.05).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 disposables sets are not available for return because they were discarded by the customer.

• Brand Name: COBE SEPCTRA
• Type of Device: COBE SPECTRA RBCX 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: 13891564
• MDR Text Key: 289196681
• Report Number: 1722028-2022-00093
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900105C
• 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
• Report Date: 03/24/2022

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 Catalogue Number: 70700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: No
• 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