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 Low Blood Pressure/ Hypotension (1914)

Event Date 04/06/2022

Event Type  Injury  

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 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.

Manufacturer Narrative

Investigation: since this was a journal publication to assess the use of dexmedetomidine for sedation during hematopoietic stem cell harvest apheresis and leukapheresis in the picu involving 18 pediatric patients over a 30-month period, 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.Regarding terumo bct product, the authors stated that the apheresis procedures were performed by personnel from versiti blood center of wisconsin.The spectra optia apheresis system made by terumo blood and cell technologies (bct) using continuous mononuclear cell (cmnc) collection protocol is the instrument used for all cellular therapy product collections.The anticoagulant (ac) is anticoagulant citrate dextrose solution, solution a (acd-a) only.We use an inlet: ac ratio of 15:1 with a maximum ac infusion rate of 1.2 milliliters (ml)/liter (l) total blood volume/minute (min) and calcium gluconate replacement of 20-40 mg/kg/hour over the duration of the procedure.Regarding events during the apheresis procedures, the authors did note sedation and procedure related complications were minimal after guideline implementation.No hypotension, fluid resuscitation or inotropic support occurred.One patient had to extend the collection slightly due to disruption from platelet clumping to ensure quality of product collection.One patient required 0.5lpm supplemental oxygen via simple nasal cannula for desaturation to the 80s.Pre-guideline, one patient experienced hypotension and required epinephrine, ivf 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 7f 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 8f cvl was needed to complete apheresis.No metabolic complications were found due to either citrate anticoagulation or fluid administration following completion of apheresis.Overall, authors concluded the implementation of this guideline with the use of dex as the standardized sedation agent during sedated hsc and lymphocyte apheresis improved efficiency during picu admission.Time intervals were shorter for initiation of sedation and apheresis, and picu length of stay decreased.Although the sedation agents were similar between the two groups, the improved efficiency could lead to potential cost savings.This guideline may be effective for use in the adult population and allow for sedated apheresis in a monitored setting outside of the picu.A risk assessment was conducted for this failure.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 root cause: based on the available information within the journal article, a definitive root cause could not be determined.The journal mentioned allegations of clumping/clotting, hypotension and a reaction that required oxygen supplementation.Potential causes for clotting/clumping include but are not limited to: - the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.- activation of platelets as a result of the patient's physiology.- size of central venous catheter - when a dual-lumen catheter is used during calcium supplementation, there is some risk of recirculation.Calcium infused at the return site could be pumped into the extracorporeal circuit rather than to the patient.This could reverse some of the effect of the citrate anticoagulation and cause clumping in the circuit.- pausing the procedure but not the calcium infusion could cause clumping in the return line and potentially the circuit.- giving a bolus of calcium rather than a continuous infusion could also increase the likelihood of clumping in the circuit.- excessive calcium infusion in combination with a higher inlet:ac ratio could lead to clotting in the circuit.The reported hypotension is a common side effect of therapeutic apheresis procedures.It is typically caused by fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.Cause for the patient's oxygen desaturation could not be determined but may be due to patient disease state and/or patient sensitivity to the procedure or sedation.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.2022.103525.

Event 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.

• 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: 15429007
• MDR Text Key: 299974582
• Report Number: 1722028-2022-00305
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/23/2024
• 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): Required Intervention