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

Catalog Number 4122201

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Nausea (1970); Vomiting (2144)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

Manufacture and expiry date are not available at this time.  investigation is in process and a follow-up report will be provided.

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) on spectra optia for deimmunization prior to heart transplantation.The patient had a baseline of 51% hematocrit.After approximately 3 hours, the patient had a first episode of nausea and vomiting with bp 85/59 mmhg.There was suspicion of vagal discomfort but they continued the procedure in view of the rapid improvement in the patient's condition.Thirty minutes later, the patient complained of feeling heat, and her blood pressure was 105/69 mmhg.The patient then complained of chest pain, and the physician ordered an ecg, finding an increase in the known above st and mirror elevation, and an unassailable hemoglobin>23 and hematocrit 70%.During the exchange the patient received 4l5 albumin.The physician stopped the procedure during the night following the procedure administered 500ml nacl 0.9% saline and 500 mg aspirin via iv to treat the 70% hematocrit.The patient is reported as "ok".Patient weight is not available at this time.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: one used optia set was received for investigation.Initial observations noted blood throughout the set.The ac, saline and product bags were not returned with the set.The inlet and return lines were connected to one replace line.A large syringe with small white tubing was returned attached to some disconnected tubing, which contained blood.Visual inspection noted the reservoir was approx.One third full and severe clotting was observed in the reservoir filter.Clumping was also noted in the inlet pressure sensor and in the channel.Witness marks on the lower hex, and on the upper and lower bearings indicated these had been loaded optimally.The roller clamps were on the correct lines and in the closed position.The set was further inspected for any kinks, missing parts or misassemblies and none were found.In summary, no disposable defects were identified.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.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.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Review of the run data file and associated aim does not show a clear root cause for the reported patient reaction.There were a total of 29 alarms during this procedure.The alarm ¿pause button was touched¿, indicating a press of the pause button, was raised total of 8 times throughout this procedure.When the pause button is pressed the system pauses all pumps and the centrifuge continues to spin.The alarm ¿replacement fluid was not detected¿ was generated a total of 9 times this procedure with the first occurring at 28 minutes into the procedure.This alarm is raised when the replacement fluid sensor does not detect fluid, suggesting more replacement fluid may need to be connected.At 167 minutes into the procedure, the alarms ¿aim system detected interface near top of channel¿ and ¿cells were detected in plasma line from centrifuge¿ were triggered a total of 3 and 2 times respectively.The first of these alarms occurs when the aim system detects that the intensity at the top of the connector is too dark, indicating that either the interface is too high in the connector or changes in blood physiology have caused the plasma to darken.The second alarm is generated when the rbc detector detects a red/green ratio greater than 1.5, suggesting there are cells in the plasma line, and may occur for various reasons including a spill over condition in the channel connector which may be the result of an entered patient hematocrit which is too low, a shift in fluid balance caused the actual hematocrit to increase, or air bubble(s) at the rbc detector.In this case, the images from the aim system showed that the interface rose in the connector, which in turn caused red cells to spill over into the plasma line at about 17:05.In tpe, the cell interface should ideally be located at the center of the channel.If the interface is near the top of the channel there is a risk of rbc spill over.For this the recommendation is to go to the patient data screen and increase the hematocrit by 3 percentage points, which in turn will decrease the plasma pump flow rate and lower the cell interface.In this procedure, the operator did increase the patient hct 3 points as soon this alarm popped and increased another 3 points later in the procedure when this alarm was triggered again.The run data file shows all systems remained in place, and the appropriate alarms were raised.There were no fluid balance alarms or any discrepancy in the signal that suggested system malfunction.From a system level, the device was found to be operating as intended.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process and a follow-up report will be provided.

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe) on spectra optia for deimmunization prior to heart transplantation.The patient had a baseline of 51% hematocrit.After approximately 3 hours, the patient had a first episode of nausea and vomiting with bp 85/59 mmhg.There was suspicion of vagal discomfort but they continued the procedure in view of the rapid improvement in the patient's condition.Thirty minutes later, the patient complained of feeling heat, and her blood pressure was 105/69 mmhg.The patient then complained of chest pain, and the physician ordered an ecg, finding an increase in the known above st and mirror elevation, and an unassailable hemoglobin>23 and hematocrit 70%.During the exchange the patient received 4l5 albumin.The physician stopped the procedure during the night following the procedure administered 500ml nacl 0.9% saline and 500 mg aspirin via iv to treat the 70% hematocrit.The patient is reported as "ok".

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 19013843
• MDR Text Key: 339043883
• Report Number: 1722028-2024-00113
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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 Catalogue Number: 4122201
• Device Lot Number: 2311273141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 80 KG