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 Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: the authors did not link the device used in granulocyte collection to the adverse events.The reported adverse events are common side effects of transfusion.There is no evidence to suggest a malfunction of the disposable kit or the spectra optia device caused or contributed to the reported adverse reactions.An investigation was conducted for a retrospective review of the clinical charts of pediatric and adult patients treated with granulocyte transfusions from january 2000 to october 2019, and analyzed the 30- and 100-day mortality rates after an initial granulocyte transfusion and correlated outcomes with granulocyte dosage administered and with clinical characteristics.Mild and moderate adverse events (aes) potentially related to the granulocyte transfusions were reported for nine (13.4 %) adults and one (1.6 %) pediatric patient.Among the adults five (7.5 %) experienced shivering, two (3%) developed a skin rash, one (1.5 %) had arterial hypotension and one (1.5 %) had dyspnea.The only report of an adverse granulocyte transfusion-related event in pediatric patients was a single (1.6 %) case of a febrile non-hemolytic transfusion reaction.No serious transfusion-associated aes were reported (e.G.Trali).By 30 days after the first granulocyte transfusion 38 (59.4 %) pediatric and 61 (91 %) adult patients had died.At 100 days post-initial transfusion, there were no additional deaths among the adults, but an additional seven pediatric patients died.Only three patients treated with granulocyte transfusions had ongoing neutrophilic dysfunction and they all survived 30 and 100 days after receiving their transfusions.The overall mortality rates 30 days after the first granulocyte transfusion was 90.7 % in patients transfused from june 2001 to february 2008, 73.8 % in those transfused from march 2008 to april 2014 and 64.3 % if the transfusion was from may 2015 to august 2019.Since this is a retrospective review of the clinical charts of pediatric and adult patients treated with granulocyte transfusions from january 2000 to october 2019, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.According to the aabb circular of information for the use of human blood components (revised 2017), hypothermia carries a risk of cardiac arrhythmia or cardiac arrest and exacerbation of coagulopathy.Rapid infusion of large volumes of cold blood or blood components can depress body temperature, and the danger is compounded in patients experiencing shock or surgical or anesthetic manipulations that disrupt temperature regulation.A blood warming device should be considered if rapid infusion of blood or blood components is needed.Warming must be accomplished using an fda-cleared blood warming device so as not to cause hemolysis.According to the aabb circular of information for the use of human blood components (revised 2017), allergic reactions frequently occur (ie, 1-3% of plasma-containing components) as mild or self-limiting urticaria or wheezing that usually respond to antihistamines.More severe manifestations, including respiratory and cardiovascular symptoms, are more consistent with anaphylactoid/anaphylactic reactions and may require more aggressive therapy (see below).No laboratory procedures are available to predict these reactions.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.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 alloimmunized 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.Root cause: a root cause assessment was performed for the adverse.The reported adverse events are common side effects of transfusion.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * rapid infusion of large volumes of cold blood or blood components.* anaphylactic 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.* febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimmunized by transfusion or pregnancy.

Event Description

The journal article, 'survival among children and adults treated with granulocyte transfusions: twenty years¿ experience at a brazilian blood center', describes a study that was conducted for a retrospective review of the clinical charts of pediatric and adult patients treated with granulocyte transfusions from january 2000 to october 2019, and analyzed the 30- and 100-day mortality rates after an initial granulocyte transfusion and correlated outcomes with granulocyte dosage administered and with clinical characteristics.Mild and moderate adverse events (aes) potentially related to the granulocyte transfusions were reported for nine (13.4 %) adults and one (1.6 %) pediatric patient.Among the adults five (7.5 %) experienced shivering, two (3%) developed a skin rash, one (1.5 %) had arterial hypotension and one (1.5 %) had dyspnea.The only report of an adverse granulocyte transfusion-related event in pediatric patients was a single (1.6 %) case of a febrile non-hemolytic transfusion reaction.No serious transfusion-associated aes were reported (e.G.Trali).By 30 days after the first granulocyte transfusion 38 (59.4 %) pediatric and 61 (91 %) adult patients had died.At 100 days post-initial transfusion, there were no additional deaths among the adults, but an additional seven pediatric patients died.Only three patients treated with granulocyte transfusions had ongoing neutrophilic dysfunction and they all survived 30 and 100 days after receiving their transfusions.The overall mortality rates 30 days after the first granulocyte transfusion was 90.7 % in patients transfused from june 2001 to february 2008, 73.8 % in those transfused from march 2008 to april 2014 and 64.3 % if the transfusion was from may 2015 to august 2019.This is a retrospective review of the clinical charts of pediatric and adult patients treated with granulocyte transfusions from january 2000 to october 2019.A request for specific donor information is not feasible.The disposable sets are not available for return.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL 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: 15054232
• MDR Text Key: 296157474
• Report Number: 1722028-2022-00235
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• 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): Other