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); Output Problem (3005)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: nguyen th, bach kq, vu hq, et al.Pre-chemotherapy white blood cell depletion by therapeutic leukocytapheresis in leukemia patients: a single-institution experience.J clin apher.2020;35(2):117-124.Doi:10.1002/jca.21766.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa was initiated to address the issue.Investigation is in process.A follow-up report will be provided.

Event Description

Per the article, journal article: pre-chemotherapy white blood cell depletion by therapeutic leukocytapheresis in leukemia patients: a single-institution experience a prospective non-comparative single-center experience investigated leukocytapheresis to reduce the white blood cell (wbc) count prior to chemotherapy.The study was conducted on 192 leukemia patients that included chronic myeloid leukemia (cml; 45.8%) acute myeloid leukemia (aml; 28.1%), acute lymphoblastic leukemia (all; 24.0%), chronic lymphocytic leukemia (cll; 1.6%), and myelodysplastic/myeloproliferative neoplasms (mds/mpn; 0.5%) diagnoses.Leukocytapheresis was conducted using the spectra optia continuous-flow centrifugal blood cell separator.The authors report that procedures were generally well tolerated with 9/192 patients reporting mild adverse events."four patients developing hypotension after the procedure, which was reversible with intravenous fluids, two patients had bleeding at the site of insertion of the peripheral needle after the procedure was completed, and three patients had muscle cramps." the authors report no occurrence of citrate toxicity or severe complications that could be attributed to the leukocytapheresis procedure.The authors concluded that "therapeutic wbc depletion by leukocytapheresis has an acceptable safety profile and an effective treatment to prevent complications of hyperleukocytosis in leukemia patients, including leukostasis and tls." exact patient details were not included in the article, therefore this report is being provided as a summary of events.The collection 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 e.1 and h.10.Investigation: per the article, the hypotension symptoms resolved following the administration of iv fluids.Per the article, "a single therapeutic leukocytapheresis procedure was initiated as soon as possible (within 6 hours from admission to the hospital), and before the leukoreduction chemotherapy with hydroxyurea started.For anticoagulation, acd-a was used at a ratio of 12:1.Approximately 4000 ml of blood (around 1.1 total blood volumes) was processed for each procedure that took ~2.5 hours.A sedimentation agent was not needed.The collection rate was adjusted according to wbc count to optimize cell removal.Total blood cell counts were assessed before and immediately after the procedure and 24 hours post-procedure.Large peripheral venous catheters were used for all patients.The safety of the leukocytapheresis procedure was assessed by evaluating hb and platelet loss, citrate side effects, and non-specific adverse effects of leukocytapheresis (such as nausea, vomiting, fainting or dizziness, seizures, skin rash and flushing, as well as risk related to venous access).Evaluation of leukocytapheresis efficiency was performed using the following parameters: median wbc removal efficiency (overall, by wbc pre-count and by diagnosis); median percentage reduction of wbcs; evaluation of median absolute wbc counts pre-, post-, and 24 hours post-leukocytapheresis (by diagnosis); fold increase in wbcs (post-count plus waste bag count vs pre-count); evaluation of median absolute hb levels and platelet counts pre-, post-, and 24 hours post-leukocytapheresis (by diagnosis).In this study, the median % reduction of wbcs was 30.5% for 186 procedures with pre- and post-counts available.The median % removal efficiency for 75 procedures where the waste bag was sampled was 46.7% (table 2).Wbc removal efficiencies for different wbc pre-count ranges (100-200, 201-300, >300 × 109/l) were not significantly different using a kruskal-wallis test with significance level.05 (p =.478 adjusted for ties) (table 2).By contrast, the removal efficiencies for different diagnoses were significantly different (p =.00001, kruskal-wallis test), with the highest median value in all patients (71%), followed by aml (66%) and cml (39%) patients (table 2).Median hb levels decreased significantly immediately after leukocytapheresis for all (p =.0155) and cml patients (p =.00001) , and increased 24 hours post apheresis for all diagnoses (p =.00008, wilcoxon signed rank test; table 4).No additional packed red cell transfusion was required after any leukocytapheresis procedure.The median platelet count was decreased immediately after leukocytapheresis in cml patients (p =.00001, wilcoxon signed rank test) but not in all and aml patients (table 4).The leukocytapheresis procedures were generally well tolerated.Out of 192 patients undergoing this procedure, nine patients had adverse effects (four patients developing hypotension after the procedure, which was reversible with intravenous fluids, two patients had bleeding at the site of insertion of the peripheral needle after the procedure was completed, three patients had muscle cramps).There were no clinical signs of citrate toxicity.There were no severe complications that could be attributed to the leukocytapheresis procedures." the authors concluded that "therapeutic wbc depletion by leukocytapheresis has an acceptable safety profile and is an effective treatment to prevent complications of hyperleukocytosis in leukemia patients, including leukostasis and tls." according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Vasovagal incidents occur around 0.5% of procedures.The 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.Since this is a retrospective study of 192 patients between (b)(6) and (b)(6) 2016, the lot numbers were not provided; therefore, a dhr search could not be conducted for these specific incidents.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: the study was conducted on 192 leukemia patients that included chronic myeloid leukemia (cml; 45.8%) acute myeloid leukemia (aml; 28.1%), acute lymphoblastic leukemia (all; 24.0%), chronic lymphocytic leukemia (cll; 1.6%), and myelodysplastic/myeloproliferative neoplasms (mds/mpn; 0.5%) diagnoses.Leukocytapheresis was conducted using the spectra optia continuous-flow centrifugal blood cell separator.Root cause : a definitive root cause for the patient reactions could not be determined.Possible causes for the reports of hypotension include but are not limited to a lower circulating blood volume, resulting in a greater percentage of the patient's blood being within the extracorporeal circuit during collection, patient disease state, concomitant medications, and/or patient sensitivity to the procedure.Possible causes for the reports of muscle cramps include but are not limited to ac management during the procedure, patient sensitivity to anticoagulant, patient disease state, concomitant medications.Possible causes for the reports of bleeding at the venipuncture site post procedure include but are not limited to venipuncture technique and/or a decrease in platelet count related to suboptimal procedure parameters (collection preference setting, collection pump rate) and/or patient disease state.

Event Description

Since this is a retrospective study of 192 patients between (b)(6) 2016, a request for patient information is not feasible.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11863832
• MDR Text Key: 252144755
• Report Number: 1722028-2021-00189
• 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: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

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 Model Number: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 07/02/2021; 07/27/2021
• Supplement Dates FDA Received: 07/06/2021; 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other