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

Catalog Number	4121201
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article "characteristics of autologous peripheral blood stem cells collection over a one-year period" by ahmetovic-karic, et alahmetovic-karic, g., catovic-baralija, e., sofo-hafizovic, a.A retrograde analysis of 24 leukapheresis in 20 adult patients with malignant hematological diseases in the blood transfusion institute of the federation of bosnia and herzegovina in sarajevo, was done.Cell separators amicus and spectra optia were used for collection procedures.Results the patient¿s age ranged from 27 to 65 years.Target cells were collected in one procedure in sixteen patients, while in four patients they were collected in two procedures.The mean cd34+ collection efficiency was (b)(4).The median number of cd34+ cells and percentage of cd34+ cells in the products were 5.52x10e6/kg (range (b)(4)) and (b)(4) (range (b)(4)).A strong positive correlation was found between the number of cd34+ cells in peripheral blood on the apheresis day and the amount of cd34+ cells collected in the products ((b)(4)).A total of (b)(4) of patients collected the amount of =3x10e6/kg and (b)(4) of =5x10e6/kg cd34+ cells for a single transplant.A decrease in platelet count, hemoglobin and hematocrit values after the procedure was not significant.Potassium decrease showed statistical significance ((b)(4)).Adverse events occurred during one procedure (b)(4).A decrease in platelet count, haemoglobin and haematocrit values in peripheral blood after leukapheresis was observed, without statistical significance ((b)(4), respectively).The median number of circulating cd34+ cells in peripheral blood on apheresis day was 62x10e6/l (range (b)(4)).Calcium and potassium values in peripheral blood decreased after the procedure, where the decrease in potassium showed statistical significance ((b)(4)) (table 4).Adverse events occurred during one procedure ((b)(4)) due to impaired blood flow through one of the lines of central venous catheter.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 at 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.
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Investigation: per the article "in conclusion, the leukapheresis procedure is fully automated and involves the use of standardized cell collection protocols.The results of this study, such as low number of adverse events and good collection efficiency with adequate patient monitoring, indicate that leukapheresis is a safe procedure that is successfully used in the autologous transplantation process in the treatment of malignant haematological diseases." investigation is in process, a follow-up report will be provided.Citation: ahmetovic-karic, g., catovic-baralija, e., & sofo-hafizovic, a.(2020).Characteristics of autologous peripheral blood stem cells collection over a one-year period.Medicinski glasnik: official publication of the medical association of zenica-doboj canton, bosnia and herzegovina, 17(2), 290¿296.Https://doi.Org/10.17392/1171-20.
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Investigation: per the article "in conclusion, the leukapheresis procedure is fully automated and involves the use of standardized cell collection protocols.The results of this study, such as low number of adverse events and good collection efficiency with adequate patient monitoring, indicate that leukapheresis is a safe procedure that is successfully used in the autologous transplantation process in the treatment of malignant haematological diseases." further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.There is no report of an injury or medical intervention for this event.No further reporting will be provided as this does not represent a reportable event.  citation: ahmetovic-karic, g., catovic-baralija, e., & sofo-hafizovic, a.(2020).Characteristics of autologous peripheral blood stem cells collection over a one-year period.Medicinski glasnik: official publication of the medical association of zenica-doboj canton, bosnia and herzegovina, 17(2), 290¿296.Https://doi.Org/10.17392/1171-20.
Event or Problem Description
Per journal article "characteristics of autologous peripheral blood stem cells collection over a one-year period" by ahmetovic-karic, et alahmetovic-karic, g., catovic-baralija, e., sofo-hafizovic, a.A retrograde analysis of 24 leukapheresis in 20 adult patients with malignant hematological diseases in the blood transfusion institute of the federation of bosnia and herzegovina in sarajevo, was done.Cell separators amicus and spectra optia were used for collection procedures.Results the patient¿s age ranged from 27 to 65 years.Target cells were collected in one procedure in sixteen patients, while in four patients they were collected in two procedures.The mean cd34+ collection efficiency was 57.7%.The median number of cd34+ cells and percentage of cd34+ cells in the products were 5.52x10e6/kg (range 3.28-9.00) and 1.57% (range 0.96-2.91).A strong positive correlation was found between the number of cd34+ cells in peripheral blood on the apheresis day and the amount of cd34+ cells collected in the products (rs=0.73).A total of 95% of patients collected the amount of =3x10e6/kg and 55% of =5x10e6/kg cd34+ cells for a single transplant.A decrease in platelet count, hemoglobin and hematocrit values after the procedure was not significant.Potassium decrease showed statistical significance (p<0.000).Adverse events occurred during one procedure (4.2%).A decrease in platelet count, haemoglobin and haematocrit values in peripheral blood after leukapheresis was observed, without statistical significance (p=0.139 and p=0.714, respectively).The median number of circulating cd34+ cells in peripheral blood on apheresis day was 62x10e6/l (range 28.99-89.38).Calcium and potassium values in peripheral blood decreased after the procedure, where the decrease in potassium showed statistical significance (p<0.000) (table 4).Adverse events occurred during one procedure (4.2%) due to impaired blood flow through one of the lines of central venous catheter.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 at 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
• Common Device Name: SPECTRA OPTIA COLLECT 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: 18951290
• Report Number: 1722028-2024-00087
• Device Sequence Number: 7965656
• Product Code: LKN
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (Y/N): N
• Initial Reporter Country: BK
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4121201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown