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

Model Number 10220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/10/2023

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.Kondo, takumi, et al.¿efficient granulocyte collection method using high concentrations of medium molecular weight hydroxyethyl starch.¿ transfusion, wiley-blackwell, june 2023, https://doi.Org/10.1111/trf.17450.

Event Description

Per journal article "efficient granulocyte collection method using high concentrations of medium molecular weight hydroxyethyl starch." by kondo et.Al citrate reactions during granulocyte apheresis were recorded in 1 of 8 procedures in each of the hhes and m0.46 groups, none in the m0.44 and m0.8 groups, and 3 of 14 procedures in m0.37 group.No further adverse events during the apheresis procedure were recorded.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.It is unknown that this time if medical intervention was required for these events.The collection 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: since this was a journal publication presenting data of a retrospective analysis of clinical and hpc collection data from autologous and allogeneic pediatric donors weighing <25 kg collected on spectra optia platform using the continuous mononuclear cell collection (cmnc) program from 2020 through 2022, the lot numbers were not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The reported adverse reactions are common side effects of therapeutic apheresis.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 median granulocyte collection efficiency (ce) was approximately 24.0% and 28.1% in the m0.8 and hhes groups, respectively, which were significantly higher than those in the m0.46, m0.44, and m0.37 groups.One month following granulocyte collection with hes130/0.4, no significant changes were observed in serum creatinine levels compared to those before the donation.Therefore, we propose a granulocyte collection approach employing hes130/0.4, which is comparable to the use of hhes in terms of the granulocyte ce.A high concentration of hes130/0.4 in the separation chamber was considered crucial for granulocyte collection.Kondo, takumi, et al.¿efficient granulocyte collection method using high concentrations of medium molecular weight hydroxyethyl starch.¿ transfusion, wiley-blackwell, june 2023, https://doi.Org/10.1111/trf.17450.Root cause: a root cause assessment was performed for the reported citrate reactions.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 physiology, 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 ac infusion rate.

Event Description

Per journal article "efficient granulocyte collection method using high concentrations of medium molecular weight hydroxyethyl starch." by kondo et.Al citrate reactions during granulocyte apheresis were recorded in 1 of 8 procedures in each of the hhes and m0.46 groups, none in the m0.44 and m0.8 groups, and 3 of 14 procedures in m0.37 group.No further adverse events during the apheresis procedure were recorded.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.It is unknown that this time if medical intervention was required for these events.The collection 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: since this was a journal publication presenting data of a retrospective analysis of clinical and hpc collection data from autologous and allogeneic pediatric donors weighing <25 kg collected on spectra optia platform using the continuous mononuclear cell collection (cmnc) program from 2020 through 2022, the lot numbers were not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The reported adverse reactions are common side effects of therapeutic apheresis.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.Investigation is in process, a follow-up report will be provided.Kondo, takumi, et al.¿efficient granulocyte collection method using high concentrations of medium molecular weight hydroxyethyl starch.¿ transfusion, wiley-blackwell, june 2023, https://doi.Org/10.1111/trf.17450.

Event Description

Per journal article "efficient granulocyte collection method using high concentrations of medium molecular weight hydroxyethyl starch." by kondo et.Al citrate reactions during granulocyte apheresis were recorded in 1 of 8 procedures in each of the hhes and m0.46 groups, none in the m0.44 and m0.8 groups, and 3 of 14 procedures in m0.37 group.No further adverse events during the apheresis procedure were recorded.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.It is unknown that this time if medical intervention was required for these events.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 17317099
• MDR Text Key: 319093086
• Report Number: 1722028-2023-00233
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183081
• 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: 07/13/2023

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: 10220
• Device Catalogue Number: 10220
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 08/28/2023; 09/12/2023
• Supplement Dates FDA Received: 08/31/2023; 09/14/2023
• 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): Other