MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA WBC SET, ISBT

Model Number 70600

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Electrolyte Imbalance (2196)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: per the article, mean collection efficiencies, shown in table 3, were 46.8% (range 30.3¿95.1) on optia and 44.3% (range 12.3¿75.2) on spectra.Collection efficiencies trended within the same range for a given patient with the two devices (data not shown).The mean platelet loss was significantly lower at 42% (range 24 ¿ 57%) on optia compared to 57% (range 42¿73%) on spectra (p=0.009).Granulocyte contamination of the stem cell component was also significantly less with optia compared to spectra (6% vs.16% respectively, p=0.01).Article citation: pudusseri, a, smith, i, et al.2018.Evaluation of a new continuous mononuclear cell collection procedure in a single transplant center cohort enriched for al amyloidosis patients.Transfusion and apheresis science.2018.57:411-415.Investigation is in process.A follow-up report will be provided.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.

Event Description

Per the article, 'evaluation of a new continuous mononuclear cell collection procedure in a single transplant center cohort enriched for al amyloidosis patients', a study was done on continuous mononuclear cell (cmnc) using spectra optia.The aim of this study is to demonstrate that the incorporation of the a cmnc program, newly introduced in 2015, on optia into the stem cell collection process for a single center patient population enriched with fragile al amyloidosis patients achieves a minimum target cd34+ dose of 2.5×106 cells/kg within 2 days of apheresis.Patients underwent leukapheresis on spectra optia for one day and cobe spectra (version 4.7, terumo bct, (b)(4)) for another day over a 2- day collection cycle; crossover sequence depended on device availability on any given day.Citrate was used exclusively as the anticoagulant without any heparin.Calcium gluconate infusion was administered through the return line, at 1 gm/h.Thirty-six consecutive leukapheresis procedures on 18 patients were performed between january and november of 2016.All collection series were completed within 2 days; only 1 did not reach the target harvest yield, requiring a second mobilization attempt one month later with g-csf and plerixafor; this was a heavily pre-treated lymphoma patient for whom poor mobilization was anticipated.Serum free calcium at the completion of each apheresis session was within normal limits except for one patient who was given diuretics just before leukapheresis.An adverse event occurred on the cobe spectra in a patient with cardiac amyloidosis who developed hypotension and diuretic-induced electrolyte disturbance necessitating early termination of apheresis.He was stabilized, continued mobilization with g-csf and plerixafor, successfully collected.Patient id, age and weight are not available at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

The disposable set was not available for return.Since this was a study to evaluate the use of the spectra optia cmnc collection procedure compared to cobe spectra during thirty-six consecutive leukapheresis procedures on 18 patients performed between (b)(6) 2016, the lot numbers are unknown.

Manufacturer Narrative

Investigation: article methods: consecutive autologous transplant patients in 2016 are included.Patients undergo leukapheresis with optia cmnc and spectra v4.7 over a 2-day cycle.Data collection includes collection efficiency, adverse events and engraftment kinetics.Article results: 36 leukapheresis procedures on 18 patients are included.The diagnoses are al amyloidosis (9), myeloma (7), lymphoma (2), and scleroderma (1).Median age is 60; 12 are men.Plerixafor was employed preemptively in 6 cycles.Median blood cd34+ on day 1 of leukapheresis was 46 cells/ul.Median number of blood volumes processed on day 1 was 3.1.All collection cycles were completed within 2 days; only one in a heavily pretreated lymphoma patient did not reach the target requiring a second mobilization attempt.Mean collection efficiencies were comparable between the two devices.There were 2 adverse events: tubing rupture on the optia; and one case of hypotension.All 18 patients underwent high-dose chemotherapy: median cell dose infused was 7.7×106 cd34+ cells/kg.Median days to neutrophil and platelet engraftment were 10 and 13 respectively.Article conclusion: the optia cmnc collection protocol is safe and effective in a small single-center autologous stem cell transplant cohort enriched for high-risk patients with al amyloidosis and cardiac involvement.Caution is needed for tubing setup because there is less cumulative experience with optia.One patient with cardiac amyloidosis developed hypotension and diuretic-induced electrolyte disturbance necessitating early termination of apheresis.The patient was stabilized with unknown medical intervention.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.Therapeutic apheresis is applied to a broad spectrum of diseases and syndromes that encompass many medical specialties and patients of all ages.Although it has become almost routine clinically, therapeutic apheresis is an invasive procedure that can have significant physiologic consequences.Not only does the majority of the patient's blood circulate extracorporeally during the procedure, but also large amounts of various solutions are returned that can potentially affect electrolytes, oncotic pressure, osmolarity, blood pressure, infection risk, coagulation, temperature control, and general homeostasis.As noted previously, the requirement for anticoagulation has a profound effect on several physiologic variables.The procedure itself leads to both hemodynamic and dilutional changes.Those physiologic consequences may also result in adverse events for the patient.Dhr details: since this was a study to evaluate the use of the spectra optia cmnc collection procedure compared to cobe spectra during thirty-six consecutive leukapheresis procedures on 18 patients performed between (b)(6) 2016, the lot numbers are unknown; therefore, a dhr search could not be conducted for the reported incident.All lots must meet acceptance criteria for release.Root cause: a definitive root cause could not be determined.The reported hypotension and electrolyte disturbance are common side effects of therapeutic apheresis procedures.Hypotension 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.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA WBC SET, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10420407
• MDR Text Key: 203683681
• Report Number: 1722028-2020-00388
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583706002
• UDI-Public: 05020583706002
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/18/2020

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: 70600
• Device Catalogue Number: 70600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Sex: Male