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

Model Number	70610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number and expiry are not available at this time.Investigation: per the article, results from these collections indicated that the spectra optia collected a higher number of cd34+ cells/kg compared to the cobe spectra (4.97 +/- 0.74 vs.3.36 +/- 0.59, respectively; p =0.05; table 2a and fig.1a).In regard to the volume of the product collected, the spectra optia had a higher product volume (413 +/- 26 ml vs.306 +/- 3 ml, respectively; p < 0.01).The hct of the product was significantly lower for the spectra optia (1.99 6 0.28% vs.4.02 6 0.18%, respectively; p < 0.01).However, the running time of the spectra optia was at least 1 hour longer per procedure compared to the cobe spectra (283 +/- 11 min vs.217 +/- 2 min, respectively; p < 0.01; fig.1b).These longer collections yielded higher decreases in plt count for the spectra optia collections compared to the cobe spectra (84 x 10e9 +/- 10 x 10e9/l vs.53 x 10e9 +/- 7 x 10e9/l, respectively; p 5 0.01; fig.1c)." li 2016 their data indicate that regardless of the nature of the collection, either autologous or allogeneic, both types of collections in the spectra optia took at least 1 hour longer when compared to the cobe spectra.This longer time period was present regardless of the diagnosis of the patient being collected since it was also seen in allogeneic donors.In addition to the longer procedure times on the spectra optia, we found a trend toward a higher percentage of plt losses in patients collected on this platform versus the cobe spectra.This finding has been previously reported and may be attributed to the increased run time and the noncontinuous nature of the mnc software.In their study, the spectra optia was not superior in regard to stem cell yield though it did provide a collection product with lower rbc contamination.Less rbc contamination has clear advantages, which include but are not limited to lower risk of hemolysis in the setting of abo-mismatched allogeneic transplants, less need for post collection processing, and to some extent a collection product which may have a higher viability and/or functionality.Article citation: li, y, li j, et al.2016.Comparison of two apheresis systems during hematopoietic progenitor stem cell collections at a tertiary medical center.Transfusion 2016; 56:2833¿2838.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 or Problem Description
Per the article, 'comparison of two apheresis systems during hematopoietic progenitor stem cell collections at a tertiary medical center', a retrospective review of 41 hematopoietic progenitor stem cell (hpsc) collections performed in 26 subjects at a tertiary medical center between june 1, 2013, and december 31, 2013, was conducted, 11 with the spectra optia and 30 with the cobe spectra.Six patients underwent two consecutive daily collections, first on the spectra optia followed by the cobe spectra.Since 2013 both apheresis systems have been used interchangeably for hpsc collections at their institution.Therefore, the goal of their study was to establish the differences between the two systems during hpsc collections to include collection yield, run time, platelet (plt) losses per collection, and red blood cell (rbc) contamination of collected product.Subjects including patients (autologous donors) or healthy matched-related donors (allogeneic donors) who were referred to their apheresis collection facility to undergo hpsc collections between june 1, 2013, and december 31, 2013, were included in the study.Software used during collections were for the cobe spectra versions (b)(4) and for the spectra optia mononuclear cell collection (mnc) software version (b)(4).Of the 26 subjects, 17 were male and nine were female.All of them were adults.For the overall cohort there was a greater incidence of signs of citrate toxicity for the spectra optia procedures (54.5%) characterized by paresthesias of face and extremities which improved with oral calcium supplementation.Similarly to what was seen for the entire cohort, 50.0% of patients who were on the spectra optia on day 1 of collection experienced signs of citrate toxicity compared to 16.7% of patients on the cobe spectra.One patient required intravenous calcium supplementation on the first day of collection with the spectra optia, which was continued on the second day of collection on the cobe spectra.This report is being filed for this patient's citrate toxicity requiring medical intervention of iv calcium on the spectra optia.Patient information is not available at this time.The disposables set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: according to anticoagulation techniques in apheresis: from heparin to citrate and beyond, citrate related complications have been reported to occur in: 1.2% of donors during voluntary donation, 7.8% of patients undergoing therapeutic plasma exchange procedures, and 48% of patients undergoing large volume leukapheresis during peripheral blood progenitor cell collection.Symptoms of hypocalcemia and other citrate-induced metabolic abnormalities affect neuromuscular and cardiac function and range in severity from mild dysesthesias (most common) to tetany, seizures, and cardiac arrhythmias.(b)(6).The lot numbers were not provided; therefore, a dhr search 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.
Event or Problem Description
This was a retrospective study between (b)(6), 2013 and (b)(6), 2013; a request for patient information is not feasible.There were a total of 26 patients, 9 female and 17 males.The age range was 23-72 years old.The weight range was 50-148 kg.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10 investigation: 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 root cause : a specific root cause for the 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 donor's or patient physiology, the patient's disease state, the rate of ac infusion, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the acda infusion rate.A definitive root cause for the platelet depletion could not be determined.Possible causes include but are not limited to: - running at a higher than optimal collection preference setting.- accumulation of buffy coat resulting in filling chamber with non-target cells.- increased run time and the noncontinuous nature of the mnc software.- patient disease state.A definitive root cause for the larger collect volumes could not be determined.Possible causes include but are not limited to: - additional chamber harvests were initiated by the operator.- large harvest volumes and/or chase volumes were configured by the operator to harvest the chamber.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10421382
• Report Number: 1722028-2020-00393
• Device Sequence Number: 19546616
• Product Code: GKT
• UDI-Device Identifier: 05020583706101
• UDI-Public: 05020583706101
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: BK150251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: 70610
• Device Catalogue Number: 10120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 07/13/2021; 07/27/2021
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 07/15/2021; 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention