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

Model Number 10310

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

Patient Problems Diarrhea (1811); Vomiting (2144); Paresthesia (4421)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: carreiro, l., gon¿alves, c., pereira, f., rom¿o, r., dami¿o, c.Complications associated with the collection of peripheral blood progenitor cells.Bone marrow transplantation.2020.55:747.Investigation is in process.A follow-up report will be provided.

Event Description

The abstract, "complications associated with the collection of peripheral blood progenitor cells" presented a study that aimed to know the incidence of complications associated with the procedure and to optimize prophylactic measures.48 patients, out of 75 aphereses, 33 males and 42 females, aged 22 to 70 years, median of 57 years, were analyzed.Diagnosis: 52% mm, 21% nhl, 20% hl, 3% systemic sclesosis, 3% leukemia dendritic cels and 1% amyloidosis.Pbpc was collected by high throughput cvc in all patients and the cell separator used was spectra optia.It was predefined the processing of 3 volemia, with an average duration of 232 minutes, collecting 100-350ml of plasma and an average of 166ml of pbpc.Prophylactic oral calcium was administered initially as 3g (64%) effervescent tablets and the lrest with 2g calcium carbonate (capsules).Cthe most frequent identified complications were paresthesia (29%), diarrhea (13%), transfusion support (7%) and vomiting (5%).Paresthesia was reported by 22 patients, with onset between 40-230 minutes, most of them in the first 120 minutes, and predominant in females (73%).Only 5 patients required iv ion replacement because symptoms persist (23%).Diarrhea always occurred after the procedure, vomiting during the procedure, both only in patients receiving effervescent calcium.3 patients needed platelet transfusion and 2 erythrocyte transfusion.Less frequent were cvc-associated complications, 1 patient with mild hemothorax resolving with symptomatic control, 1 hematoma and 2 cvc bleeding from the insertion site.The abstract did not provide individual patient details, therefore this report is being filed as a summary of the patients and events.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation : per the article: the investigators sought to identify and quantify the complications associated with the collection of peripheral blood progenitor cells (pbpc) in order to optimize prophylactic measures.Statistical analysis was performed on all patients who collected pbpc from 1.01 to 16.09.2019.There was a total of 48 patients, out of 75 apheresis, 33 males and 42 females, aged 22 to 70 years, median of 57 years, were analyzed.Regarding the diagnosis: 52% mm, 21% nhl, 20% hl, 3% systemic sclerosis, 3% leukemia dendritic cells and 1% amyloidosis.Pbpc was collected by high throughput cvc in all patients and the cell separator used was spectra optia.All procedures processed 3 total blood volumes, with an average duration of 232 minutes, collecting 100-350 ml of plasma and an average of 166 ml of pbpc.Prophylactic oral calcium was administered initially as 3g (64%) effervescent tablets and the latter with 2g calcium carbonate (capsules).The authors concluded that prophylactic measures are an effective support because only 5 patients required iv ion replacement.Changing the therapeutic form of prophylactic calcium to capsule form was beneficial in the absence of nausea, vomiting and diarrhea.It was recommended that patients maintain care with a diet rich in calcium and other ions, as per leaflet.According to anticoagulation techniques in apheresis: from heparin to citrate and beyond, citrate related complications have been reported to occur in: 1.2% of donors during voluntary donation, 7.8% of patients undergoing therapeutic plasma exchange procedures, and 48% of patients undergoing large volume leukapheresis during peripheral blood progenitor cell collection.Symptoms of hypocalcemia and other citrate-induced metabolic abnormalities affect neuromuscular and cardiac function and range in severity from mild dysesthesias (most common) to tetany, seizures, and cardiac arrhythmias.Since this was a retrospective study, 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

To clarify the reportable event: the retrospective study from 1.01 to 16.09.2019, analyzing a total of 75 pbpc collections on 48 patients, reported the following adverse events: five (5) patients experienced citrate reactions requiring iv ca2+ replacement, three (3) patients required platelet transfusions, and two (2) patient¿s required rbc transfusions.Additionally, ten (10) patients experienced diarrhea and four (4) patients had incidents of vomiting (medical intervention was not listed for these reactions).This was a retrospective study 33 males and 42 females, aged 22 to 70 years.A request for specific patient information is not feasible.

Manufacturer Narrative

This report is being filed to provide investigation: 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,light headedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.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.Root cause: a definitive root cause for the citrate reactions could not be determined.Possible causes include but are not limited to ac management during the procedure, a long procedure, patient disease state, and/or patient sensitivity to anticoagulant.A definitive root cause for the platelet depletion could not be determined.Possible causes include but are not limited to: - running at a higher than optimal collection preference setting, resulting in a product with a higher platelet count and low hematocrit.- running at a higher than optimal collect flow rate, leading to more product collected and, therefore, a greater platelet loss.- improper anticoagulation of the extracorporeal circuit, leading to activation of platelets.- patient's adverse pathological condition.- a long procedure time.A definitive root cause for the red cell depletion could not be determined.Possible causes include but are not limited to: - running at a lower than optimal collection preference setting, resulting in a product with a high hematocrit.- haze on the camera window or equipment defect.- inaccurate entry of patient's data - patient's adverse pathological condition.A definitive root cause for the reported vomiting and diarrhea could not be determined.Possible causes include but are not limited to: - administration of effervescent calcium.- complications associated with patient's underlying disease state.- side effects due to chemotherapy.- side effects as a result of stem cell mobilization regimen (e.G.Pain at the injection site, fever, chills, and a deep-aching pain in the bones that may require pain medication.Subjects also may experience fatigue, headache, insomnia, loss of appetite, nausea and vomiting.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11528909
• MDR Text Key: 255097372
• Report Number: 1722028-2021-00122
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 10
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other