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

Model Number	10120
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the article, 'dexmedetomidine for sedation during hematopoietic stem cell harvest apheresis and leukapheresis in the picu: guideline development', continuous mononuclear cell (cmnc) collection protocols were used on high-risk pediatric patients who required sedation for hematopoietic stem cell (hsc) harvest apheresis procedures.A guideline was developed to provide a standardized sedation plan for the high-risk patients requiring hsc or lymphocyte apheresis in the picu with the use of dexmedetomidine.Prior to apheresis, these patients all have central venous access either with their existing central venous catheters, ports, or require placement of an apheresis catheter (cvl), in interventional radiology (ir).One patient had to extend the collection slightly due to disruption from platelet clumping to ensure quality of product collection, another patient required 0.5l supplemental oxygen via simple nasal cannula for desaturation to the 80s.Pre-guideline, one patient experienced hypotension and required epinephrine, iv fluid bolus, electrolyte replacements and halting of the apheresis procedure until the following day.Three patients required second or third days in the picu for repeat sedated apheresis while no repeat apheresis occurred after guideline implementation.Clotting complications were found in all patients with 7 f cvl placed in ir (2 pre and 2 post) which either delayed initiation or paused the apheresis.Either tissue plasminogen activator (tpa) or rewiring to 8 f cvl was needed to complete apheresis.Specific details for each patient are not provided in the article, therefore this report is being filed as a summary of events.The disposable sets are not available for return for analysis.
Additional Manufacturer Narrative
Lot number and expiry are not available at this time.Investigation is in process, a follow-up report will be provided.Article citation: magner k, mikhailov t, simpson p, et al.Dexmedetomidine for sedation during hematopoietic stem cell harvest apheresis and leukapheresis in the picu: guideline development.Transfusion and apheresis science.2022.(b)(4).
Event or Problem Description
Per the article, 'dexmedetomidine for sedation during hematopoietic stem cell harvest apheresis and leukapheresis in the picu: guideline development', continuous mononuclear cell (cmnc) collection protocols were used on high-risk pediatric patients who required sedation for hematopoietic stem cell (hsc) harvest apheresis procedures.A guideline was developed to provide a standardized sedation plan for the high-risk patients requiring hsc or lymphocyte apheresis in the picu with the use of dexmedetomidine.Prior to apheresis, these patients all have central venous access either with their existing central venous catheters, ports, or require placement of an apheresis catheter (cvl), in interventional radiology (ir).One patient had to extend the collection slightly due to disruption from platelet clumping to ensure quality of product collection, another patient required 0.5l supplemental oxygen via simple nasal cannula for desaturation to the 80s.Pre-guideline, one patient experienced hypotension and required epinephrine, iv fluid bolus, electrolyte replacements and halting of the apheresis procedure until the following day.Three patients required second or third days in the picu for repeat sedated apheresis while no repeat apheresis occurred after guideline implementation.Clotting complications were found in all patients with 7 f cvl placed in ir (2 pre and 2 post) which either delayed initiation or paused the apheresis.Either tissue plasminogen activator (tpa) or rewiring to 8 f cvl was needed to complete apheresis.Specific details for each patient are not provided in the article, therefore this report is being filed as a summary of events.The disposable sets are not available for return for analysis.
Additional Manufacturer Narrative
It has been determined that the event submitted on this report is a duplicate of the event submitted on report 1722028-2022-00305.Article citation: magner k, mikhailov t, simpson p, et al.Dexmedetomidine for sedation during hematopoietic stem cell harvest apheresis and leukapheresis in the picu: guideline development.Transfusion and apheresis science.2022.(b)(4).

• 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: 15428829
• Report Number: 1722028-2022-00304
• Device Sequence Number: 20016036
• Product Code: GKT
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Literature,Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 05/23/2024
• 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: Required Intervention
• Patient Sex: Unknown