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

Model Number 12320

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

Patient Problems Reaction (2414); Cough (4457)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that 15 minutes into a continuous mononuclear cell (cmnc) collection procedure, a patient with lymphoma began to cough.The physician ordered to stop the procedure and to push 50mg iv benadryl, due to possible eto reaction.Prior to the procedrue, the patient was stable with a heart rate of 120bpm.The customer declined to provide the patient identifier and age.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 h6 & h10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable search history was performed for this lot.No additional reports of similar issues were found.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.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: per the customer, they will perform a saline rinse before the next cmnc procedure.Root cause: based on customer's statements about the allergic reaction and the literature review, the cause for the patient's reaction was a result of her sensitivity to eto.

Event Description

Per the customer, the patient is stable.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10522377
• MDR Text Key: 206550607
• Report Number: 1722028-2020-00441
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• 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: 09/11/2020

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: 02/01/2022
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2002243130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 10/01/2020; 10/07/2020
• Supplement Dates FDA Received: 10/06/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75