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

Model Number 10310

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Rash (2033)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.No definitive root cause for the reported adverse patient reactions could be identified from the dlog associated with this procedure.There were no signals to indicate the device contributed to the adverse patient reactions reported.Investigation is in process.A follow-up report will be provided.

Event Description

Per the customer, 10 minutes after procedure started, during custom priming for a continuous mononuclear cell (cmnc) collection procedure anaphylaxis occurred.The patient experienced stomachache, hives, rash, hypotensive reaction.The patient was given steroid medication after the procedure.The doctor thought that the cause of anaphylaxis was whole blood which they used with custom priming.The doctor submitted the whole blood for investigation.Per the customer, the patient injury was not directly related to optia product.The issue was anaphylactic shock due to red blood cells (rbc).Current patient status is recovered.The customer declined to provide patient identifier.Terumo bct is awaiting return of the disposable set.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: according to the aabb circular of information for the use of human blood components (revised 2017).Febrile nonhemolytic reactions are typically manifested by a temperature elevation of >1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Anaphylactic reactions, characterized by hypotension, tachycardia, nausea, vomiting and/or diarrhea, abdominal pain, severe dyspnea, pulmonary and/or laryngeal edema, and bronchospasm and/or laryngospasm, are rare (<10/100,000 transfused units) but dangerous complications requiring immediate treatment with epinephrine.While these reactions have been reported in iga-deficient patients with anti-iga antibodies and patients with haptoglobin deficiency, most reactions are idiosyncratic and not associated with a specific serum protein deficiency, polymorphism, or identifiable cause.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in investigation: upon follow-up with the customer, the terumo bct representative learned that "the other day, after the issue, the patient received the medical treatment through optia successfully without custom priming as the doctor infused blood component prior to the optia procedure".It is unknown if the patient was pre-medicated for the second procedure.A disposables history search for lot 2007213230 found no other reports for allergic/anaphylactic reaction worldwide.Since there was no report of adverse events related to the second procedure, it is likely the adverse event from the first procedure was not related to the patient's sensitivity to the disposable set.A five year complaint history search found no other reports of allergic/anaphylactic reactions following custom prime.Additional rdf analysis: the run data file confirmed that a blood warmer was not used.The custom prime was configured using 270 ml packed rbcs at 55% hematocrit, and it was completed at 12:13 pm.The procedure started at 12:18 pm, and a total of 123 ml of fluid was processed by the return pump while the patient was connected, before it was terminated shortly after the patient experienced an anaphylactic reaction.Performing a custom prime helps to maintain isovolemia when the patient has a low rbc volume or a low total blood volume, such as in this case, a pediatric patient.After the custom prime is complete and the run is started, the fluid used is pumped from the channel to the patient before the system establishes the interface.Estimated return flow rate = 123 ml/10 min = 12.3 ml/min based on return flow rate of 12.3 ml/min, the custom red cells were transfused at approximately 46.1 ml/kg/hr.No definitive root cause for the reported adverse patient reactions could be identified from the dlog associated with this procedure.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to this event.Quality labs and sterilization requirements all passed.Correction: discussion with the physician concluded that a slow blood transfusion prior to the optia treatment would probably prevent allergic/anaphylactic reactions during the optia procedure since optia¿s slowest inlet flow rate is 5ml/min.Based on this suggestion to infuse a unit of red blood cells prior to the procedure, the physician performed another collection on the patient, without custom prime, and reported a successful outcome.Investigation is in process.A follow up report will be provided.

Event Description

The disposable set was not available for return.Per the customer, the lab test results of wb custom prime unit and whether the patient underwent a stem cell collection prior to the procedure are not available.

Manufacturer Narrative

This report is being filed to provide additional information in d.4, h.4, e.1, h.6 and h.10 and corrected information in g.4.Investigation: per internal medical review and analysis, the device did not cause or contribute to this incident.Root cause: a definitive root cause of the alleged anaphylactic reaction could not be determined.Possible causes include but are not limited to: - a reaction to the custom prime red blood cell unit due to: - immediate hypersensitivity reaction (production of ige antibodies in response to allergens (plasma proteins)) - plasma protein deficiency (iga deficiency (iga < 0.05 mg/dl); formation of anti-iga igg antibodies) - haptoglobin deficiency - passive sensitization (passive transfer of donor allergens or donor antibodies (e.G.Allergen-specific ige); transient allergic sensitivity to allergens - the return flow rate was too high during the return of custom prime blood.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11562651
• MDR Text Key: 242671647
• Report Number: 1722028-2021-00128
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2021

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 Expiration Date: 07/01/2022
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 2007213230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 04/07/2021; 05/03/2021; 05/17/2021
• Supplement Dates FDA Received: 04/16/2021; 05/10/2021; 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00004 YR
• Patient Weight: 16