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

Catalog Number 12220

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

Patient Problems Dizziness (2194); Swelling/ Edema (4577)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer confirmed that the device was not being operated in caution status mode.The customer has recently been converted to the correct connect tubing kits and acd-a.The device history record was reviewed for this lot.There were no issues noted.All quality labs and sterilization requirements passed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a patient reaction that occurred during a therapeutic plasma exchange (tpe) procedure on a spectra optia device.Per the customer, the patient complained of swollen eyes, scratchy throat, palor, lightheaded, dizzy, and hot.The attending physician decided to abort the procedure and ordered 50 mg of benadryl by iv.Per the customer, the patient recovered quickly and was discharged home.Calcium gluconate was administered prior to the procedure at a rate of 25mg/kg/hr for the duration of the procedure for a total of 2,025mg 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 disposable lot query was performed for lot 2101213130 and no similar reported occurrences were received against this lot to date.Per the customer, the same patient underwent another tpe procedure earlier on feb 25 and experienced a reaction, but did not require a medical intervention for that event.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 for the patient's reaction could not be determined.Possible causes for the patient's reaction include but are not limited to an allergy to replacement solution and/or patient sensitivity to eto.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11575205
• MDR Text Key: 242671010
• Report Number: 1722028-2021-00129
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 12220
• Device Lot Number: 2101213130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00016 YR
• Patient Weight: 75