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

Catalog Number 10220

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

Investigation: 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%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported a patient had an allergic reaction of rashes and itching on the face, neck, hands during a therapeutic plasma exchange (tpe) procedure.Medical intervention for the reaction was injection of hydrocortisone, 2cc of avil and dexamethasone.The patient recovered after antihistamines and steroid injections.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported a patient had an allergic reaction of rashes and itching on the face, neck, hands during a therapeutic plasma exchange (tpe) procedure.Medical intervention for the reaction was injection of hydrocortisone, 2cc of avil and dexamethasone.The patient recovered after antihistamines and steroid injections.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide investigation: 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%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the run data files did not indicate a root cause for the reported patient reactions stated for the tpe procedures called out in this complaint.The system operated as intended and the procedures were run without incident.There were no signals or alarms in the dlog that would indicate issues during the run, specifically the amount of ac delivered.The commanded ac pump speed and the measured ac pump speed were accurate and did not show any discrepancy in pump volume.The ac infusion rate was set to 1.2ml/min/ltbv for all procedures.This rate can be adjusted down if it is not well tolerated by the patient.The inlet:ac ratio remained at the default value of 12 as this ratio will properly anticoagulant the system.Both of these values can be adjusted at any time during the run as needed.Note that all procedures had fresh frozen plasma (ffp) as the replacement solution in which the optia system assumes a 15% citrate content conservatively.Furthermore, the optia system offers the ability to perform an additional saline rinse after the tubing set has been primed with saline if hypersensitivity reactions associated with residual ethylene oxide in the tubing set (a result of sterilization) are suspected for the patient.This option is explained in the spectra optia operators manual under selecting procedure options root cause: a root cause assessment was performed for the allergic reactions.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * hypersensitivity to the ethylene oxide used to sterilize the disposable set.* hypersensitivity to the components inside the disposable set.* hypersensitivity to the replacement fluids, such as fresh frozen plasma (ffp) * patients underlying disease state or sensitivity to the apheresis procedure.

• 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: 18150107
• MDR Text Key: 328299120
• Report Number: 1722028-2023-00376
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/16/2023

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: 10220
• Device Lot Number: 2304143144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2023
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 80 KG