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

Model Number 10120

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: per the article, "cd34 collection efficiencies (ce2) of 51.9 6 1.7% (mean 6 sem) and 57.5 6 3.0% were observed in autologous and allogeneic procedures, respectively.After implementation of the algorithm, the mean number of collections per patient declined from 1.97 to 1.5.Accordingly, the frequency of patients requiring single- day collections increased from 35% to 57%.All donors were collected in single procedures, although only 12.2 6 1.1 l blood was processed, including for national marrow donor program collections.Cumulative procedure time, processed blood volume, product volume, infused anticoagulant volume, and symptomatic calcium administration decreased in patients, and overcollection was limited." "ce2 was somewhat higher in the allogeneic group, possibly due to the younger age of the healthy donor population, presenting with veins that are easier to access.Also, fewer pressure alarms and stable inlet flow rates were witnessed in allogeneic collections as opposed to autologous collections, which allow for a good buffy coat separation in the centrifuge." (leberfinger 2017).Article citation: leverfinger, dl, badman, kl, et al.2017.Improved planning of leukapheresis endpoint with customized prediction algorithm: minimizing collection days, volume of blood processed, procedure time, and citrate toxicity.Transfusion 2017; 57:685¿693.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.Investigation is in process.A follow-up report will be provided.

Event Description

Per the article, 'improved planning of leukapheresis endpoint with customized prediction algorithm: minimizing collection days, volume of blood processed, procedure time, and citrate toxicity' (leberfinger 2017), a retrospective analysis was performed on 107 hpc collections completed on the spectra optia mnc from january 2013 to june 2014 in 51 patients and 12 donors.In december 2014, a prediction algorithm was implemented, designed from data acquired since january 2013, by linear regression of preapheresis cd34 cell counts (pre-cd34) versus collected cd34 cell dose per volume blood processed.All apheresis collections were performed on the spectra optia (terumo bct) using the mnc protocol (software versions 6, 9, and 11).A 12:1 inlet:anticoagulant (ac) ratio was used for both allogeneic and autologous procedures, with a mean infusion rate of 0.9 ml/min/tbv (range, 0.7-1.2 ml/min).Calcium was administered symptomatically: oral calcium carbonate supplementation (2 3 750 mg) or intravenous (iv) calcium gluconate (2 g in 50-500 ml normal saline solution).From the 94 autologous procedures, five procedures required iv administration of calcium gluconate, and in six procedures both iv calcium gluconate and oral calcium carbonate were administered.Exact details regarding patient information were not included in the article, therefore, this report is being provided as a summary of these events.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 h.6 and h.10.Investigation: a 12:1 inlet: anticoagulant (ac) ratio was used for both allogeneic and autologous procedures, with a mean infusion rate of 0.9 ml/min/tbv (range, 0.7-1.2 ml/min).Calcium was administered symptomatically: oral calcium carbonate supplementation (2 3 750 mg) or intravenous (iv) calcium gluconate (2 g in 50-500 ml normal saline solution).From the 94 autologous procedures, 22 procedures (23%) required symptomatic calcium administration.For 11 procedures oral calcium carbonate supplementation was sufficient, five procedures required iv administration of calcium gluconate, and in six procedures both iv calcium gluconate and oral calcium carbonate were administered.Ce2 was somewhat higher in the allogeneic group, possibly due to the younger age of the healthy donor population, presenting with veins that are easier to access.Also, fewer pressure alarms and stable inlet flow rates were witnessed in allogeneic collections as opposed to autologous collections, which allow for a good buffy coat separation in the centrifuge.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.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.The optia essentials guide advises the operator of possible adverse effects of apheresis procedures and to be prepared to take appropriate action should any reactions occur.Some previously reported reactions are: anxiety, headache, light-headedness, digit and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension, allergic reactions.Patient and donor characteristics: autologous, allogeneic, male/female: 26/25, (b)(6) donor age (years), 58.0+/-1.2, 29.6+/-3.4 donor weight (kg), 93.6+/-8.7 recipient weight (kg), 87.0+/-2.2 , 97.9+/-7.7 dhr: since this retrospective analysis was performed on 107 mobilized mnc collections at a single institution from january 2013 to june 2014, 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.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 donor physiology, 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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10413930
• MDR Text Key: 209824514
• Report Number: 1722028-2020-00380
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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: 10120
• Device Catalogue Number: 10120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/30/2016
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/12/2022
• 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