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

Model Number 10310

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

Patient Problem Blood Loss (2597)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: sanderson, f, poullin, p, et al.2016.Peripheral blood stem cells collection on spectra optia apheresis system using the continuous mononuclear cell collection protocol: a single center report of 39 procedures.Journal of clinical apheresis.2017;182¿190.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

Per the article, 'peripheral blood stem cells collection on spectra optia apheresis system using the continuous mononuclear cell collection protocol: a single center report of 39 procedures', a study was performed to assess the performance of continuous mononuclear cell collection (cmnc) protocol on the spectra optia apheresis system for collecting autologous peripheral blood stem cells (pbsc) in adult patients with respect to collection variables.In this retrospective study, 39 cmnc procedures on 23 mobilized patients with multiple myeloma and lymphoma were analyzed.Apheresis-related adverse events (p.185): though all patients were supplemented with iv calcium, 2 minor citrate side effects (grade 1: headache, paresthesia limited to limb extremities and around the mouth) were reported, reversed by decreasing the whole blood inlet and amending the citrate infusion rate.All sessions were completed, processing the required target blood volume with no major technical hazards encountered.One patient with a 25% starting session hct ended at 19%, experienced symptomatic anemia and had to be transfused.One other subject had a platelet count dropping from 22 to 18 x 109/l after completion of apheresis but without bleeding.Engraftment-related adverse events (p.187): one patient who experienced a seizure after cell product (cp) transfusion.The transplanted cp contained 218 x 109/l of wbc with 51% of polymorphonuclear and the volume was 186 ml.This complication had no vital consequences, the patient recovered with no sequellae and the transplantation process was achieved normally.Exact details regarding the patients that experienced reactions, including patient information and outcomes, were not included in the article, therefore, this report is being provided as a summary of the adverse events noted in article.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 b.5 and h.10.Investigation: per the article, "cytapheresis were performed when a blood cd34 cells count over 10/ml was reached.Patients were selected for cmnc protocol only if their wbc was at least 10 x 10^9/l.The cmnc protocol using idl disposal set were used on soas version 11 software.After priming, cmnc protocol starts with a phase of interface definition.The cmnc program fixes an initial default collection preference to 50.This parameter may be adjusted by the operator according to the color of the collection line assisted by a colorgram.To reduce granulocytic contamination as these cells are deeper in the layers of the buffy coat, the target hct was fixed at 2 to 3%.The collection pump flow rate was set unchanged at 1 ml/minute.Anticoagulant (acd) ratio was 1:12, but could be increased in case of aggregates on the collection line or decreased in case of clinical citrate side effects, while the inlet flow is slowed.In our practice we perform large volume leukapheresis, targeting three times the patient¿s total blood volume (tbv).The procedure could be shortened according to the cd34 cells enrichment or the results of previous harvests.The target of the collections was to reach a cd34 dose of at least 4 x 10^6/kg body weight in patients with lymphoma and 8 x 10^6/kg in patients with multiple myeloma.All patients were supplemented preventively with 10% gluconate calcium by a continuous intravenous infusion throughout the session at one gram per hour into the return line via a three way tap.Thirty five procedures were completed using peripheral venous access, and four using a femoral double lumen catheter." "the median cp platelets count was 834 x 10^9/l (iqr 487¿ 1070.5) with an absolute platelet count of 1.88 x 10^11 (iqr 1.10¿2.48) but the median ce1 was low at 14.9% (iqr 13.0 ¿ 17.6) with a median platelet count reduction of 27.3% (iqr 21.2 ¿ 32.8) after apheresis.Platelet loss could be also explained by a dilutional effect on the post procedure sample due to the important volume of infused acd.The absolute wbc and polynuclear cell count in the cp was respectively 39.25 x 10^9 (31.17¿54.50) and 4.16 x 10^9 (iqr 1.30¿10.98).The median mnc differential was 65% (iqr 53¿84.5) and the polynuclear cells 9,0% iqr 4 ,5¿22,5), other cross contaminating cells were myelemic white blood cells.We were unable to demonstrate any correlation between mnc purity (percentage and absolute cell count) and hct (figure 1)." 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 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.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.Dhr details: this is a retrospective data analysis of 39 cmnc procedures in 23 adult patients from (b)(6) 2014 to (b)(6) 2015, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.

Event Description

This is a retrospective data analysis of 39 cmnc procedures in (b)(4) eligible for mobilized autologous stem cell apheresis.The median age was 57 years old (30¿68) and the median weight 69 kg (44¿108).A request for specific patient information is not feasible.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: a definitive root cause for the reported citrate reactions could not be determined.These reactions occur 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.A definitive root cause for the platelet and rbc losses could not be determined.The authors stated that "platelet loss could be also explained by a dilutional effect on the post procedure sample due to the important volume of infused acd." other possible causes for platelet loss include but are not limited to: - patient's underlying disease state - cp was set too high - clumping in the extracorporeal system - running a lengthy procedure - collect flow rate was set too high a definitive root cause for the rbc losses could not be determined.Possible causes for rbc depletion include but are not limited to: - patient's blood physiology interferes with separation of cellular components and chamber triggering (i.E.Abnormal rbcs, hyperviscous plasma) - incorrect setting of collection preference - the presence of a small buffy coat which resulted in red cells getting collected along with the target cells.- inaccurate entry of the patient's hematocrit - inlet flow rate was too high to adequately separate red cells from buffy coat - rbc port height is too high - improper loading of the channel into the filler - hazy camera window which causes the light to diffuse around the collect port.This makes the collect port appear light, even when rbcs are flowing through the port.- lighting is too bright due to improperly calibrated diffuser plate.One patient who experienced a seizure after cell product (cp) transfusion.The transplanted cp contained 218 x 10^9/l of wbc with 51% of polymorphonuclear and the volume was 186 ml.This complication had no vital consequences, the patient recovered with no sequellae and the transplantation process was achieved normally.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10417266
• MDR Text Key: 209195524
• Report Number: 1722028-2020-00385
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK150251
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/20/2022
• 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