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

Catalog Number	10220
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Citation: jo, t., arai, y., kitawaki, t., nishikori, m., mizumoto, c., kanda, j., yamashita, k., nagao, m., & takaori-kondo, a.(2023).Risk analysis of fluctuating hypercalcemia after leukapheresis in cellular therapy.Scientific reports, 13(1).Https://doi.Org/10.1038/s41598-023-42159-1 investigation is in process, a follow-up report will be provided.
Event or Problem Description
Per journal article "risk analysis of fluctuating hypercalcemia after leukapheresis in cellular therapy" by tomoyasu jo, yasuyukiarai, toshio kitawaki, momoko nishikori, chisaki mizumoto, junya kanda, kouheiyamashita, miki nagao, akifumitakaori, kondo potential adverse event: in (b)(4) subjects (b)(4), 1 h post-leukapheresis, ica concentration was above the upper limit of normal.In (b)(4) subjects (b)(4), ica con-centration was below the lower limit of normal range at the end of leukapheresis, but rose above the upper limit of the normal range 1 h after the end of leukapheresis, with a prominent rise during the first hour after the end.These results suggest that hypercalcemia occurs after leukapheresis in the majority of subjects.Calcium supplementation provided.The collection set is not available for return because it was discarded by the customer.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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Lot number, manufacture and expiry date are not available at this time.Citation: jo, t., arai, y., kitawaki, t., nishikori, m., mizumoto, c., kanda, j., yamashita, k., nagao, m., & takaori-kondo, a.(2023).Risk analysis of fluctuating hypercalcemia after leukapheresis in cellular therapy.Scientific reports, 13(1).Https://doi.Org/10.1038/s41598-023-42159-1 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.Per review, all patients received iv calcium gluconate solution during t-cell and stem cell collections, which is standard practice for these types of collections and does not constitute medical intervention.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
Per journal article "risk analysis of fluctuating hypercalcemia after leukapheresis in cellular therapy" by tomoyasu jo, yasuyukiarai, toshio kitawaki, momoko nishikori, chisaki mizumoto, junya kanda, kouheiyamashita, miki nagao, akifumitakaori kondo potential adverse event: in 58 subjects (76.3%), 1 h post-leukapheresis, ica concentration was above the upper limit of normal.In 33 subjects (43.3%), ica con-centration was below the lower limit of normal range at the end of leukapheresis, but rose above the upper limit of the normal range 1 h after the end of leukapheresis, with a prominent rise during the first hour after the end.These results suggest that hypercalcemia occurs after leukapheresis in the majority of subjects.Calcium supplementation provided.The collection set is not available for return because it was discarded by the customer.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.

• Brand Name: SPECTRA OPTIA
• Common Device Name: 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: 20401109
• Report Number: 1722028-2024-00434
• Device Sequence Number: 20398633
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 10220
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/25/2024
• 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