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

Model Number 10220

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/19/2022

Event Type  Injury  

Event Description

The customer reported that during a procedure a patient had a reaction.It is unknown at this time if medical intervention was required for this event.Patient information and outcome are not available at this time.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Lot number, expiry and manufacture date are not available at this time.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in a.2, a.3, a.4, b.5, b.6, b.7, e.1 and h.10.Corrected information is provided in a.1, b.3 and b.5.Lot number, expiry and manufacture date are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure a patient had a reaction.The customer reported that the patient became tachycardic and flushed during the 2nd to last infusion of the ffp.The patient was given benadryl 25 and the 50 mg ivp and famotidine 20 mg ivp.Per the customer the patient was discharged to home and is in stable condition.The disposables 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 (b)(4).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 lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: based on customer's statement and patient symptomology, the cause for the patient's reaction is believed to be related to an allergy to the replacement solution.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure a patient had a reaction.The customer reported that the patient became tachycardic and flushed during the 2nd to last infusion of the ffp.The patient was given benadryl 25 and the 50 mg ivp and famotidine 20 mg ivp.Per the customer the patient was discharged to home and is in stable condition.The disposables set is not available for return because it was discarded by the customer.

• 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: 13803988
• MDR Text Key: 287811965
• Report Number: 1722028-2022-00085
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• 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,Followup,Followup
• Report Date: 03/17/2022

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 Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/18/2022
• Supplement Dates Manufacturer Received: 04/13/2022; 01/20/2023
• Supplement Dates FDA Received: 05/07/2022; 01/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 50 KG