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

Model Number	10120
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number and expiry are not available at this time.Article citation: ojha, s., poojary, m., mokalikar, u., sumathi, s.H., kumar, a., gupta, a.M., and saha, s.The determinants of donor safety and product quality in optimization of apheresis granulocyte harvest: an experience from a tertiary care oncology centre in india, transfusion and apheresis science, (2022) doi:https://doi.Org/10.1016/j.Transci.2022.103445.Investigation is in process.A follow up report will be provided.
Event or Problem Description
The journal article, 'the determinants of donor safety and product quality in optimization of apheresis granulocyte harvest: an experience from a tertiary care oncology centre in india' describes a retrospective study on 131 healthy allogeneic donors who underwent granulocyte harvest from may 2016 to july 2020.Donors were mobilized for granulocyte harvest 10-12 hours before collection with 10 ¿g/kg subcutaneous injection of g-csf plus 8 mg oral dexamethasone tablets and were subjected to apheresis collection using different cell separators like cobe spectra mnc system (terumo bct), fresenius com.Tec mnc system (fresenius kabi), and spectra optia mnc system (terumo bct).Donor's ages ranged between 20 to 55 years with a median age of 32 years and included 129 males and two female donors.Adverse events (aes) were observed in overall 29 procedures (22.13%), including 14.50% citrate reactions, 7.6% venous access-related reactions, and 1.52% vasovagal reactions.All the aes were classified as grade i and grade ii as per the common terminology criteria for adverse events (ctcae) grading version 5.0, which required minimal intervention.- iv calcium for reaction.The article did not provide specific patient information, therefore this report is being provided as summary of events.The collection sets are not available for return for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10 lot number and expiry are not available at this time.Article citation: ojha, s., poojary, m., mokalikar, u., sumathi, s.H., kumar, a., gupta, a.M., and saha, s.The determinants of donor safety and product quality in optimization of apheresis granulocyte harvest: an experience from a tertiary care oncology centre in india, transfusion and apheresis science, (2022) doi:https://doi.Org/10.1016/j.Transci.2022.103445 investigation: 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.It was confirmed that there was no mention of medical intervention for the citrate toxicity.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The journal article, 'the determinants of donor safety and product quality in optimization of apheresis granulocyte harvest: an experience from a tertiary care oncology centre in india' describes a retrospective study on 131 healthy allogeneic donors who underwent granulocyte harvest from may 2016 to july 2020.Donors were mobilized for granulocyte harvest 10-12 hours before collection with 10 ¿g/kg subcutaneous injection of g-csf plus 8 mg oral dexamethasone tablets and were subjected to apheresis collection using different cell separators like cobe spectra mnc system (terumo bct), fresenius com.Tec mnc system (fresenius kabi), and spectra optia mnc system (terumo bct).Donor's ages ranged between 20 to 55 years with a median age of 32 years and included 129 males and two female donors.Adverse events (aes) were observed in overall 29 procedures (22.13%), including 14.50% citrate reactions, 7.6% venous access-related reactions, and 1.52% vasovagal reactions.All the aes were classified as grade i and grade ii as per the common terminology criteria for adverse events (ctcae) grading version 5.0, which required minimal intervention.- iv calcium for reaction.The article did not provide specific patient information, therefore this report is being provided as summary of events.The collection sets are not available for return for evaluation.

• 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: 15815756
• Report Number: 1722028-2022-00369
• Device Sequence Number: 5661059
• Product Code: GKT
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: 10120
• Device Catalogue Number: 10120
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/05/2023
• 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