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 Reaction (2414); Sweating (2444)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a neuromylitis opticia patient had a transfusion reaction during a therapeutic plasma exchange (tpe) procedure with albumin on a spectra optia device.Per the customer, 45 min into the run the patient's experienced shortness of breath, rash, their face was deep red, stuffy nose, scratchy throat and sweating.The procedure was ended 5 min later.Per the customer, once the procedure was stopped the catheter was flushed the symptoms were resolved and a blood transfusion work up was done.The customer reported that the patient did not have respiratory distress.The customer reported the patient had a treatment following this one and did fine with the albumin.The customer reported that patient is stable and the symptoms were resolved following the treatment.The customer declined to provide the patient identifier.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the patient reaction as experienced by the customer.Root cause: a definitive root cause for the patient's reaction could not be determined.Based on customer's statements about the allergic reaction and the literature review, possible causes for the patient's reaction include but are not limited to an allergy to replacement solution and/or patient sensitivity to eto.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.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.A disposable search history was performed for this lot.No additional reports of similar issues were found.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9654501
• MDR Text Key: 188236153
• Report Number: 1722028-2020-00040
• 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,Followup
• Report Date: 01/31/2020

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 Expiration Date: 10/01/2021
• Device Catalogue Number: 10220
• Device Lot Number: 1910293130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 03/06/2020; 03/30/2020
• Supplement Dates FDA Received: 03/18/2020; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00057 YR
• Patient Weight: 82