MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA AUTOPBSC SET, ISBT

Model Number 70610

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

Patient Problem Reaction (2414)

Event Date 06/14/2016

Event Type  Injury  

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 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 4.7 and 6.1 and for the spectra optia mononuclear cell collection (mnc) software version 8.0.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 cobe spectra.Patient information is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: since this was a retrospective study between june 1, 2013 and december 31, 2013, 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.The patient's symptoms were resolved with intravenous calcium supplementation and the iv calcium was administered to the patient during a second procedure on the next day as well.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 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.See attached.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 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 lower collection efficiencies could not be determined.Possible causes include but are not limited to: patient's blood physiology interferes with separation of cellular components (i.E.Abnormal rbcs, hyperviscous plasma).Poor mobilization of target cells due to donor's or patient's physiology and mobilization regimen.Not processing enough blood to optimize the collection of target cells.Entry of incorrect wbc and/or platelet counts.Poor access, which resulted in pump pauses and caused the system to repeatedly re-establish the interface.Platelet clumping which can interfere with proper separation of cells in the connector and/or chamber and can also cause system to repeatedly re-establish the interface.Changes to the inlet pump flow rate.Configuration of harvest and chase volumes (auto pbsc protocol) a definitive root cause for the stem cell products contaminated with a high rbc count could not be determined.Possible causes include but are not limited to: patient's or donor's blood physiology interferes with separation of cellular components (i.E.Abnormal rbcs, hyperviscous plasma).100% manual interface control (mnc protocol) can lead to subjective interface management (changes to plasma flow rate).Visual management and interpretation of hct in collect line can lead to higher hct in the stem cell product (mnc protocol).

Event Description

This was a retrospective study between june 1, 2013 and december 31, 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.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA AUTOPBSC SET, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10414471
• MDR Text Key: 209391930
• Report Number: 1722028-2020-00382
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583706101
• UDI-Public: 05020583706101
• Combination Product (y/n): N
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• 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: 70610
• Device Catalogue Number: 70610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention