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

Model Number 10310

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Immunodeficiency (2156); Electrolyte Imbalance (2196)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: navarro, l., moreno, d., bartual, m., pe¿alver, m., d¿az, m., planells, y., lopez, m., lezina, b., fuentes, c., solves, p., fernandez navarro, j., carpio, n., g¿mez segu¿, i.Extracorporeal photopheresis (ecp) in pediatric patients: a single-centre experience.Vox sanguinis.2020.115:57 investigation is in process.A follow-up report will be provided.

Event Description

The abstract, "extracorporeal photopheresis (ecp) in pediatric patients: a single-centre experience" aims to evaluate the feasibility and efficacy of ecp in pediatric patients." adverse events reported were most problems during sessions were related to cvc dysfunction (70/516; 13%), but only 3 sessions had to be aborted.The remaining incidents were light hypocalcemia (n=8; 1.5%), ecp-related anemia (n = 7; 1.3%), technical device problems (n = 6; 1%) and hypotension (n = 1).Problems were equally frequent in both ecp systems and patients < or >25 kg.Due to the nature of the report in a publication, additional details on the claims was not provided.The abstract did not provide specific details regarding patient information or medical intervention, therefore, this report is being filed as a summary of events.The disposable set is not available for return because it was discarded by the customer.This report is being filed due to patient death, though at this time, there is no allegation that the device caused of contributed to the death.

Manufacturer Narrative

This report is being filed to provide additional information in b.7 and h.10.Investigation: per the article, the methods used were: "all patients <18 years and treated with ecp were included.During 2013-2015 we used the in-line method (cellex, therakos) with treatment schedule of 2 sessions per week (acute gvhd) or every two weeks (chronic gvhd).From 2016 on, off-line system with spectra optia (cmnc, terumo bct) and illumination in uva-pit (medtech solutions) or macogenic g2 (macopharma) was employed.Treatment schedule was 2 sessions per week (agvhd) or once a week (cgvhd), followed by one session every two weeks.Per protocol, blood volume processed per session was 1500 ml in cellex and 1tbv in spectra optia.Small weight patients (<25 kg) received intravenous calcium and blood prime of the apheresis system.Ecp-related problems and response were assessed retrospectively.Efficiency was calculated with ce2 formula.Chi2/fisher and mann-whitney u test were used using ezr version 1.41." results of the study: "a total of 516 ecp sessions during 27 treatment episodes in 23 patients were included in this study (two patients had three episodes) [6f/17m, median age 8 years.(range 1-16), median weight 29 kg (range 8-86)].In 6/27 episodes ecp was performed in-line.Median number of sessions per patient was 16 (range 2-47) during a median of 5 mo.(range 0.25-15).Half of treatments were performed in patients <25 kg (n = 262).Indication of treatment was cgvhd in 10/27 (37%) cases and agvhd in the remaining ones [involving skin (23/27; 85%), gut (10/27;37%) and liver (6/27; 22%)].Central venous catheter (cvc) was used in 85% of cases.Two patients died before the first month of treatment.The remaining patients showed complete response (n = 8; 32%), partial response with >50% reduction of immunosuppression (n = 5; 20%) or <50% of reduction (n = 3; 12%) or no response (n = 9; 36%) at the end of treatment." 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, e.1, g.2, h.6 and h.10.Investigation: 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.Since this was retrospective study between 2013 and 2015, including 516 ecp procedures, the disposable lot numbers were not provided and the sets were not available for return.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Hypotension reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.According to pediatric therapeutic apheresis: a critical appraisal of evidence, there is limited data available on the incidence and characteristics of adverse events occurring during and immediately following pediatric apheresis (pa) procedures.The retrospective published data show large variability.The largest cohort of patients was published by the italian registry of pediatric therapeutic apheresis.Using a survey-based format, this study included 1693 ta procedures in 355 children.Adverse events were noted in 94 procedures (5.6%).The most common complications were insufficient flow rate (50%) and symptomatic hypocalcemia (24.4%).In another study, michon et al reported on the incidence of adverse events in 186 children undergoing 1632 ta procedures from 1994 to 2002.This study reported an adverse event rate of 55% for all pediatric procedures.The most common complications were hypotension (48.4%), hypotension requiring fluid bolus (26.9%), and symptomatic hypocalcemia (28.5%).The potential for adverse events to arise in children undergoing pediatric apheresis (pa) procedures is most likely higher than in adults.Patient-related factors including small blood volumes, inadequate vascular access, and inability to communicate with the apheresis provider make ta procedures more precarious in pediatrics.Additionally, apheresis instruments are not designed to accommodate the small blood volumes of children; this results in the need for albumin or rbc priming of the instruments to avoid hemodynamic changes or profound red cell mass shifts.Decisions as to whether to divert the initial fluid prime back to the patient or perform "rinseback" of the remaining fluid in the machine are made based on the patient's ability to tolerate such shifts.Furthermore, the slower inlet rates typically seen in small children are also problematic because access lines may clot.Because of the child's small veins, large-bore double-lumen central venous lines, multiple peripherally inserted central catheters, or ports need to be placed.Unlike adult studies, pediatric studies need to be designed with an understanding of the technical and procedural modifications necessary for smaller blood volumes and immature organ systems.Root cause: a definitive root cause for the reports of hypocalcemia could not be determined.Possible causes include but are not limited: - ac and calcium management during the procedure - patient's pathological condition - patient sensitivity to anticoagulant a definitive root cause for the report of hypotension could not be determined.Possible causes or contributing factors include but are not limited to: - patient's pathological condition - fluid dynamic shift during the procedure - patient's sensitivity to the procedure a definitive root cause for the reports of ecp-related anemia could not be determined.Possible causes include but are not limited to: - patients' underlying disease state - techniques used to custom prime the instruments resulting in hemodynamic changes or profound red cell mass shifts the authors did not elaborate on the nature and root causes of the technical problems.A definitive root cause for the reported technical device problems could not be determined.Possible root causes include but are not limited to: - a disposable defect - a device malfunction - an operator error - issues with patients' access - inadequate technical training - inadequate technical and procedural modifications made to accommodate for pediatric patients.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.No additional information was provided by the author during contact attempt.Correction: the statement "this report is being filed due to patient death, though at this time, there is no allegation that the device caused of contributed to the death." provided in the initial mdr is no longer relevant to this event as no death occured with use of tbct devices.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11436384
• MDR Text Key: 239469382
• Report Number: 1722028-2021-00097
• 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,l
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other