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 Problems Chest Pain (1776); Cough (4457)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

Lot number, manufacture date and expiry date are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

Per the journal article "ethylene oxide-type hypersensitivity reactions in g-csf mobilized, peripheral blood hematopoietic progenitor cell donors and review.J clin apher.2023." by cooling, l.,sherbeck, j.Published 3/15/23.Three autologous hpcc donors experienced eto-type reactions within 15 min of initiating hpcc, for a 10-year incident rate of 0.08% per procedure and 0.18% per donor.All three reactions occurred using the spectra optia and idl tubing set, for an optia/idl specific rate of 0.2% per procedure and 0.5% per donor.There was no correlation between eto reactions, eosinophil counts, or saline prime dwell times.No patient had classic predisposing risk factors for eto hypersensitivity.Two patients required medical intervention whereas the third responded by pausing the procedure and slowing the inlet rate.All three patients had coughing within 15 minutes of initiating hpcc using the spectra optia and idl tubing set.Two patients had additional symptoms including throat irritation/itching, o2 desaturation, and chest pressure.Two patients required the administration of antihistamines and steroids: one patient responded by pausing and then resuming collection at a slower inlet rate.The patient was a 66-year-old white male with a history of stage iiia follicular lymphoma (grade 3a), treated with six cycles of r-chop (rituximab, doxorubicin, vincristine, prednisolone) complicated by severe clostridium difficile colitis, bowel perforation, and colectomy requiring a 6-week hospitalization.The patient remained in remission for nearly 3 years before developing diffuse large b-cell lymphoma.He was initially treated with three cycles of rituximab, ifosfamide, carboplatin, and etoposide with only partial remission, followed by three cycles of rituximab, gemcitabine, oxaliplatin, and external beam radiation.His other medical history was significant for chronic kidney disease, depression, and gastroesophageal reflux disease.The patient's drug intolerances included metronidazole (fever and mental status changes) but no drug allergies.He was referred to our facility for hpcc and autologous hsct.For hpcc, the patient was mobilized with cyclophosphamide (2 g/m2 /day, day 0) and g-csf (10 mcg/kg) starting day +6, with the first hpcc scheduled for day +11.On arrival for his first hpcc, he was fatigued and tired with mild bone pain and complaints of insomnia.His current medications included omeprazole, sertaline, and ibuprofen.In addition, the patient had taken diphenhydramine the prior evening to facilitate sleep.His physical exam was unremarkable except for a well-healed scar along his lower abdomen and a colostomy.His vital signs were stable and within normal limits (bp 132/70, pulse 93 bpm, and rr 16/min).Hpcc was performed on the spectra optia and idl tubing set using cmnc program and antecubital piv for venous access.The patient received no premedication and the tubing set was primed with normal saline per routine.20 within minutes of starting the procedure, the patient developed chest tightness, a persistent cough, and new onset lacrimation.The patient had no nausea, vomiting, abdominal pain, difficulty swallowing, lightheadedness, or loss of consciousness.Pulse oximetry showed decreased oxygen saturation (spo2) = 84% on room air (ra).A physical exam revealed slightly diminished breath sounds in all lung fields, but no wheezing.There was no perioral or periorbital edema, rash or urticaria.The procedure was paused and patient given diphenhydramine (50 mg, iv), methylprednisolone (100 mg, iv), loratadine (10 mg, oral), and oxygen (3 l, nasal cannula [nc]).Over the course of 20 minutes, his cough resolved with spo2 = 93%¿96% on ra.The procedure was restarted at a slow inlet rate (40 ml/min), with the rate gradually increased to 65 ml/min after 1 hour.The patient remained asymptomatic and the procedure was completed without further events.His cd34 yield after processing three blood volumes was 1.7 106 /kg.The following day he returned for a second hpcc.To minimize eto exposure, the tubing set was doubleprimed with saline to elute and wash out eto.20 in addition, the patient was premedicated with 50 mg iv diphenhydramine: methylprednisolone was held unless the patient experienced symptoms.The patient underwent a second day of collection without allergic symptoms, and successfully reached a total of 3.3 106 cd34/kg.The collection set is not available for return because it was discarded by the customer.Specific details were not included in the article for this event.

Event Description

Per the journal article "ethylene oxide-type hypersensitivity reactions in g-csf mobilized, peripheral blood hematopoietic progenitor cell donors and review.J clin apher.2023." by cooling, l.,sherbeck, j.Published 3/15/23.Three autologous hpcc donors experienced eto-type reactions within 15 min of initiating hpcc, for a 10-year incident rate of (b)(4) per procedure and (b)(4) per donor.All three reactions occurred using the spectra optia and idl tubing set, for an optia/idl specific rate of (b)(4) per procedure and (b)(4) per donor.There was no correlation between eto reactions, eosinophil counts, or saline prime dwell times.No patient had classic predisposing risk factors for eto hypersensitivity.Two patients required medical intervention whereas the third responded by pausing the procedure and slowing the inlet rate.All three patients had coughing within 15 minutes of initiating hpcc using the spectra optia and idl tubing set.Two patients had additional symptoms including throat irritation/itching, o2 desaturation, and chest pressure.Two patients required the administration of antihistamines and steroids: one patient responded by pausing and then resuming collection at a slower inlet rate.The patient was a 66-year-old white male with a history of stage iiia follicular lymphoma (grade 3a), treated with six cycles of r-chop (rituximab, doxorubicin, vincristine, prednisolone) complicated by severe clostridium difficile colitis, bowel perforation, and colectomy requiring a 6-week hospitalization.The patient remained in remission for nearly 3 years before developing diffuse large b-cell lymphoma.He was initially treated with three cycles of rituximab, ifosfamide, carboplatin, and etoposide with only partial remission, followed by three cycles of rituximab, gemcitabine, oxaliplatin, and external beam radiation.His other medical history was significant for chronic kidney disease, depression, and gastroesophageal reflux disease.The patient's drug intolerances included metronidazole (fever and mental status changes) but no drug allergies.He was referred to our facility for hpcc and autologous hsct.For hpcc, the patient was mobilized with cyclophosphamide (2 g/m2 /day, day 0) and g-csf (10 mcg/kg) starting day +6, with the first hpcc scheduled for day +11.On arrival for his first hpcc, he was fatigued and tired with mild bone pain and complaints of insomnia.His current medications included omeprazole, sertaline, and ibuprofen.In addition, the patient had taken diphenhydramine the prior evening to facilitate sleep.His physical exam was unremarkable except for a well-healed scar along his lower abdomen and a colostomy.His vital signs were stable and within normal limits (bp 132/70, pulse 93 bpm, and rr 16/min).Hpcc was performed on the spectra optia and idl tubing set using cmnc program and antecubital piv for venous access.The patient received no premedication and the tubing set was primed with normal saline per routine.20 within minutes of starting the procedure, the patient developed chest tightness, a persistent cough, and new onset lacrimation.The patient had no nausea, vomiting, abdominal pain, difficulty swallowing, lightheadedness, or loss of consciousness.Pulse oximetry showed decreased oxygen saturation (spo2) = 84% on room air (ra).A physical exam revealed slightly diminished breath sounds in all lung fields, but no wheezing.There was no perioral or periorbital edema, rash or urticaria.The procedure was paused and patient given diphenhydramine (50 mg, iv), methylprednisolone (100 mg, iv), loratadine (10 mg, oral), and oxygen (3 l, nasal cannula [nc]).Over the course of 20 minutes, his cough resolved with spo2 = 93%¿96% on ra.The procedure was restarted at a slow inlet rate (40 ml/min), with the rate gradually increased to 65 ml/min after 1 hour.The patient remained asymptomatic and the procedure was completed without further events.His cd34 yield after processing three blood volumes was 1.7 106 /kg.The following day he returned for a second hpcc.To minimize eto exposure, the tubing set was doubleprimed with saline to elute and wash out eto.20 in addition, the patient was premedicated with 50 mg iv diphenhydramine: methylprednisolone was held unless the patient experienced symptoms.The patient underwent a second day of collection without allergic symptoms, and successfully reached a total of 3.3 106 cd34/kg.The collection set is not available for return because it was discarded by the customer.Specific details were not included in the article for this event.

Manufacturer Narrative

Investigation: since this was a journal publication presenting data of a prospective study to assess the efficacy and safety of tpe using spectra optia to evaluate the impact of standard-volume pe (svpe) on 21-day transplant-free survival in acute liver failure (alf) patients over a period from january 2016 to september 2018, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.To identify eto-type reactions, a retrospective review was performed of all adult hpcc-related ae recorded during the last 10 years (january 7, 2010-june 30, 2021).Reactions were attributed to eto based on the onset of allergic signs and symptoms within 30 minutes of initiating hpcc.Symptoms consistent with allergic reactions included rash, urticaria, pruritis, throat tickling/throat clearing, facial flushing, conjunctival injection, lacrimation, angioedema, chest tightness/pain, hypoxia, bronchospasm, and anaphylaxis.Exclusion criteria for eto reaction included blood transfusion immediately prior to hpcc, latex allergy, recent use of an acei, and presence of allergic symptoms prior to hpcc.A chart review was performed for all potential eto cases.Collected data included primary and secondary patient diagnoses; past cancer treatment; current medications including acei, loratadine, or other antihistamine; history of allergies, asthma or allergic bronchitis; stem cell mobilization method (g-csf, plerixafor, chemotherapy); venous access (peripheral iv [piv], central venous catheter [cvc]); apheresis instrumentation/software; apheresis collection flow sheets; peripheral blood counts (wbc, cd34, and eosinophil) and cd34 cell yields.No serum ige results were available.No patient was tested for eto sensitivity by either skin test or serology due to lack of local test availability.The absolute eosinophil counts were examined in the three index eto cases and 55 consecutive adult hpcc performed between december 5, 2021 and december 7, 2021.The hpcc donor control group consisted of 18 cytokine-mobilized autologous (5 lymphoma, 13 multiple myeloma [mm] and 14 allogeneic donors).There were no recorded allergic-type reactions among the 32 control donors.Eosinophil counts were performed on an automated cell counter (sysmex xe-5000, kobe, japan).Eosinophil counts were compared at baseline (premobilization) and post mobilization (pre leukapheresis and post leukapheresis).A pre procedure absolute eosinophil count was available in all donors.All adult hpcc collections were scheduled for morning collection, with machine setup and saline prime finished by 8 am.The saline prime dwell time was defined as the length of time from priming the machine with saline (8 am) and the initiation of hpcc as recorded in procedure flowsheets.The saline dwell time was determined in all three patients and 34 consecutive adult hpcc during august 2021 and analyzed by venous access and procedure day.A 10-year retrospective review of all ae documented during adult autologous and allogeneic hpcc identified eight allergic-type reactions.Five allergic reactions (blood transfusion, urticarial/rash skin reactions from g-csf administration) were excluded from further analysis leaving a total of three eto-type allergic reactions.In two patients (cases 1 and 2), the nature of the reaction was identified by medical staff as an eto-allergic reaction and documented in the medical record.The third case was identified upon retrospective review.A detailed chart review was performed in all three patients as detailed below (table 1).All three patients were >60 years old with no history of asthma, atopy, documented drug or seasonal allergies, extracorporeal procedures (dialysis, cardiac surgery, apheresis), or ace inhibitors.All three patients had coughing within 15 minutes of initiating hpcc using the spectra optia and idl tubing set.Two patients had additional symptoms including throat irritation/itching, o2 desaturation, and chest pressure.Two patients required the administration of antihistamines and steroids: one patient responded by pausing and then resuming collection at a slower inlet rate.All three patients were able to finish the procedure and successfully collected sufficient cells for hematopoietic stem cell transplant (hsct).In summary, we report that eto-type reactions can occur in g-csf-mobilized patients undergoing hpcc.Unlike most previously reported eto reactions, none of our patients had a history of asthma, atopy, prior apheresis, or dialysis.We also found no correlation between increased eosinophil counts and eto symptoms.Eto hypersensitivity should be considered in any patient experiencing allergic-type symptoms within the first 15 to 30 minutes of initiating leukapheresis or other apheresis procedures.Active treatment of eto allergic reactions includes pausing the procedure and administration of antihistamines, steroids, oxygen, fluids, and/or beta agonists as clinically indicated.In patients with mild symptoms, the procedure can often be resumed at a slower inlet rate with symptoms resolving with increasing blood volume processed.Patients with documented prior eto reactions should receive premedication with antihistamines.In addition, the tubing set should be saline washed twice (double-primed) to flush eto from the system prior to connecting the patient.In highly atopic patients, it may require several saline rinses and an aggressive premedication regimen similar to that used for iv contrast allergies.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Root cause: a root cause assessment was performed for the allergic reactions.The authors concluded that the reactions were a result of hypersensitivity to the ethylene oxide used to sterilize the disposable sets.

• 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: 16736282
• MDR Text Key: 313302311
• Report Number: 1722028-2023-00143
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: White