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

Catalog Number 12220

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

Patient Problems Fever (1858); Itching Sensation (1943); Rash (2033)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation: per the customer, there were no issues with the machine prior to the initial reaction symptoms.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 3 units into a red blood cell exchange (rbcx) procedure on a spectra optia device, a sickle cell patient experienced a reaction.The patient had a rash, itching, tachycardia and fever.The patient was pre- prescribed tylenol, solucortef and benadryl.A transfusion reaction workup was done and there was no issue found with the blood.Per the customer, the procedure was double primed with washed red blood cells.It was reported that the patient has had procedures before and not had a reaction.The patient is currently stable and listed as outpatient status.Per the customer medical intervention given was iv benadryl and iv solumedrol for the itching, tachycardia and hives.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 event.Investigation is in process.A follow-up report will be provided.

Event Description

Per the customer medical intervention was given iv solucortef and pepcid gtt (plus benadryl) for the rash, itching, tachycardia and fever.Per the customer, calcium gluconate and acd-a were also used during the procedure.

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.The device history record (dhr) was reviewed for this lot.There were no issued identifed that would have contributed to the event experienced by the customer.This product has been processed with eto to achieve a 10-6 sterility assurance level in accordance with en iso 11135.This product has been validated to achieve less than 6mg eto, meeting the requirements of iso 10993-7 prior to release and less then 1ppm in the collect bag at time of use.All sterilization requirements passed.A 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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: a definitive root cause 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: 9504390
• MDR Text Key: 183308532
• Report Number: 1722028-2019-00429
• 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,Followup
• Report Date: 12/20/2019

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: 09/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1909103130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/20/2019; 01/27/2020; 02/12/2020
• Supplement Dates FDA Received: 12/20/2019; 02/05/2020; 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00034 YR
• Patient Weight: 59