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 Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Electrolyte Imbalance (2196); 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, nguyen nq, duong td, wheeler j.Therapeutic thrombocytapheresis in myeloproliferative neoplasms: a single-institution experience.J clin apher.2021;36(1):101-108.Doi:10.1002/jca.21847.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

The journal article, "therapeutic thrombocytapheresis in myeloproliferative neoplasms: a single- institution experience" describes a study that employed a prospective non-comparative approach to report a single-institution experience on thrombocytapheresis (plateletpheresis) procedures performed in myeloproliferative neoplasms (mpns) patients between january 2016 and june 2017.A total of 185 mpn patients underwent thrombocytapheresis procedures using the spectra optia apheresis system, resulting in 183 evaluable procedures.The authors explain that plateletpheresis procedures may report complications related to vascular access (hematoma, thrombosis, perforation of artery, sepsis through catheter site, surgical shunts, or fistulas), procedural problems (vasovagal, hypovolemic, hypotensive, mechanical hemolysis, air embolus, citrate toxicity, chills, rigors, or nausea), and effects of replacement fluids (allergic reactions, electrolyte imbalance, and citrate toxicity).In this study, the authors reported that 13/185 mpn patients had mild adverse events occur (1 patient had hematoma at the site of vein puncture, 4 patients had hypotension, which was reversible with intravenous fluids, and 8 patients had muscle cramps).The article states that these adverse events were reversible and relatively easy to manage.No severe complications could be attributed to the thrombocytapheresis procedure, and the authors state that the use of peripheral venous access resulted in fewer problems with bleeding and hematoma at the venipuncture site, leading to easier nursing care.To note, "136 patients (73.5%) experienced vasomotor symptoms before apheresis (eg, dizziness, vertigo, vascular headache).After completion of the procedure, 91 out of these 136 patients (66.9%) achieved symptom relief to various extents.Exact patient details were not included in the article, therefore this report is being provided as a summary of events.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: 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.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.Adverse effect related to vascular access are a frequent concern.Hematoma, venous sclerosis, and thrombosis can complicate percutaneous needle puncture.The optia essentials guide advises the operator of possible adverse effects of apheresis procedures and to be prepared to take appropriate action should any reactions occur.Some previously reported reactions are: anxiety; headache; light-headedness; digit and/or facial paresthesia; fever; chills; hematoma; hyperventilation; nausea and vomiting; syncope (fainting); urticaria; hypotension; allergic reactions according to the article, the equipment used was a continuous-flow centrifugal blood cell separator: spectra optia (software version 11.2).For anticoagulation, acid citrate dextrose solution a (acd-a) was used at a ratio of 12:1.Approximately 4000 ml of blood (around 1.1 blood volumes) was processed for each procedure, which took approximately 2 to 2.5 hours.A sedimentation agent was not needed.The collection rate was adjusted according to platelet count to optimize cell removal.Peripheral venous access was used for all patients.A single thrombocytapheresis procedure was initiated as soon as possible (within 6 hours from admission to the hospital), and before the hydroxyurea chemotherapy and/or aspirin treatment started.The median percentage reduction of platelets was 44.5% and the median percentage removal efficiency was 65.2% for 83 procedures where the waste bag was sampled.The hb level was decreased after thrombocytapheresis for both diagnoses (essential thrombocythemia (et) and chronic myeloid leukemia (cml)) as a result of a loss of red blood cells through contamination of the buffy coat layer due to density overlap.However, hb concentration reduction was not clinically significant, as can be seen from adverse effects data.The wbc count was decreased after thrombocytapheresis.This can be explained by the similarity of platelets compared to leukocytes.The density of platelets is not significantly different from that of immature myeloid cells (ranges from 1.063 g/ml for myeloblasts to 1.080 g/ml for neutrophils).Therefore, platelets may be contaminated with wbcs and both may be removed from the circulation during apheresis, especially in case of cml patients with very high wbc counts.Since this was a prospective non-comparative approach to report a single-institution experience on thrombocytapheresis, 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.Investigation is in process.A follow up report will be provided.

Event Description

The authors also stated that the hb level and wbc count were decreased after thrombocytoapheresis, and both were deemed not clinically significant.This was a prospective, non-comparative study involving 97 males and 88 females, aged 4 to 86 years.A request for specific patient information is not feasible.

Manufacturer Narrative

Root cause: a definitive root cause for the patients' reaction could not be determined.Possible causes for the hypotension include but are not limited to patient's sensitivity to the hemodynamic stress of the procedure and/or the patient's disease state.A definitive root cause for the reported citrate reactions could not be determined.These reactions occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the patient's disease state, the rate of ac infusion, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.Possible causes for hematoma include but are not limited to: poor phlebotomy technique in association with difficult access or fragile vessels.Rapid return flows in some procedures can cause leakage of blood from the vessels into the surrounding tissue.Unsecured needle as a result of arm movement during procedure that compromised needle position.The authors attributed the loss of red blood cells through contamination of the buffy coat layer to density overlap.They stated that the loss of wbc can also be explained by the similarity of density between platelets and leukocytes.Therefore, platelets may be contaminated with wbcs and both may be removed from the circulation during apheresis, especially in case of cml patients with very high wbc counts.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11863811
• MDR Text Key: 252161192
• Report Number: 1722028-2021-00188
• 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

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other