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

Model Number 12320

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

Patient Problem Confusion/ Disorientation (2553)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient started an infusion of a second aliquot of progenitor cells (unfrozen).The patient presented with discomfort, a feeling of faintness and confusion, a vacant gaze and normoreactive pupils.She was responsive to call with monosyllables.The patient had been hypotensive since the start of the infusion, the infusion was stopped, and the bag of cells was sent to the laboratory for calculation of the remaining cells.Life-saving measures were carried out with lev, new dose of corticosteroid, furosemide.Patient identifier, weight and outcome are not available at the time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in investigation: transfusion reaction/platelets: 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.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimunized by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial.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 reacations 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 b.5, h.6 and h.10.Investigation: information was requested to aid in the investigation; however, the customer did not provide further details.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide the patient's weight and id.

Manufacturer Narrative

Investigation: a disposable history search indicated there were no other reported occurrences of adverse reactions on this lot worldwide.Per literature review (kazuhiko ikeda, et al, transfusion medicine reviews, 2018), nausea/vomiting, fever, and allergic reactions were most frequent in allo-pbscts.In a multivariate analysis, a history of transfusion reactions was a risk factor for overall aes in all hematopoietic stem cell transplants (hscts).For grade =2 aes in allo-hscts, a history of transfusion reactions for overall aes, and high infusion volume and allo-pbscts (versus bmts, or=9.948, p=.002) for allergic reactions were identified as risk factors.These findings suggest that some factors unrelated to dmso, such as allo-antigens, contribute to hsc infusion-related aes.On april 23, 2021, the customer sent a letter with additional details regarding the incident: reviewing the medical history shows that the patient has always had arterial stresses below 90/60 and had a moderate to severe history of covid-19 in november 2020 with a chest ct scan on november 25, 2020 that showed parenchymal densities in patches and ground glass opacification mainly affecting the upper lobes with a small amount of bilateral pleural effusion consistent with covid-19 infection.It was also found that the patient had been pre-medicated for the infusion of hpc with hydrocortisone and 50 mg of diphenhydramine.The patient's blood pressure was 75/50 at the beginning of the infusion of the first unit and 77/37 at the end; then it was 85/61 during the infusion of the second unit.Therefore, it is unlikely that the transient hypotension and tachycardia are associated with the infusion of cells since the patient had a history of low functional figures and also received medications that may induce hypotension and tachycardia.The customer further explained: an adverse event related to the infusion of progenitor cells was ruled out, neurological involvement was never confirmed clinically or in images, and in evaluation with endocrinology, the possibility of suprarenal insufficiency was raised, explaining the persistent arterial hypotension in a patient with chronic use of corticothérapie.Root cause: the specific root cause of the patient's reaction could not be determined.Based on the clinical findings as well as the customer statements, the reaction was related to the patient's pathological condition and/or the medications which were administered to the patient prior to the infusion.

Event Description

The patient was given an additional dose of hydrocortisone and furosemide to resolve the reaction and was stabilized.The customer did not provide the patient weight.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11436434
• MDR Text Key: 243131223
• Report Number: 1722028-2021-00099
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• 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: 03/08/2021

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: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2007313130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 03/23/2021; 04/20/2021; 04/28/2021
• Supplement Dates FDA Received: 03/30/2021; 04/21/2021; 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention