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

Catalog Number 4122201

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

Patient Problems Tachycardia (2095); Diaphoresis (2452)

Event Date 01/18/2023

Event Type  Injury  

Event Description

The customer reported an incident where the patient had an adverse reaction during a therapeutic plasma exchange (tpe) procedure which required a medical intervention.Per the customer, the replacement fluid used was fresh frozen plasma.The patient's heart rate went up and blood pressure dropped and it was reported that the patient became diaphoretic approximately 1 hour into the procedure.The physician was notified and the patient was given 650 mg tylenol per oral, 25 mg ivp benadryl, 4 mg ivp zofran and 2 gm ivp calcium gluconate.They had to call a rapid response.Per the customer, the patient was stable and fine.The exchange set is not available for return for evaluation.

Manufacturer Narrative

Investigation: 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.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the patient reaction experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Root cause: based on the clinical findings and the patient symptomatology, the cause for the patient's reaction is believed to be related to an allergy to the replacement solution, fresh frozen plasma.

• 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: 16356890
• MDR Text Key: 309322617
• Report Number: 1722028-2023-00054
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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: 2211156141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2022
• 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: 38 YR
• Patient Sex: Male
• Patient Weight: 90 KG