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

Catalog Number 10220

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

Patient Problems Rash (2033); Tachycardia (2095); Reaction (2414)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are unknown at this time.Investigation is in process.A follow up report will be provided.

Event Description

During a customer site visit, a terumo bct representative was informed by the customer of a patient reaction that had occurred during a red blood cell exchange (rbcx) procedure.Per the customer, this was the patient's third or fourth rbcx.The patient experienced a rash, was itchy, complained of palpitations, was tachycardic, dizzy and complained of feeling like her throat was swelling, but upon examination no swelling was observed.The doctor at the customer site believes the reaction may have due to ethylene oxide (eto).An ig test was ordered to determine if it was an eto reaction, however, results are not available at this time.It is unknown at this time if any medical intervention was necessary for the patient reaction.Patient identifier, age, weight, and outcome are not available at this time.Exact incident date is unknown at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

Additional information was requested from the clinical services director, since the relevant information regarding both the patient and the procedure is missing and not obtainable no further details can be provided by the customer.Since the specific information regarding both the patient and the procedure is missing and not obtainable, the clinical services director at the customer site cannot provide further details on any medication prescribed, and/or the patient's condition.Patient was in her late 20s or early 30s.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.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 root cause: a definitive root cause of the patient's reaction could not be determined.Possible causes include but are not limited to: - sensitization to eto (ethylene oxide), leading to hypersensitivity reactions - patient physiology and/or medical condition - unknown, concurrent medication side effects - blood product transfusion reaction.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9739777
• MDR Text Key: 185974278
• Report Number: 1722028-2020-00076
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other