MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA PLATELET PLASMA SET

Catalog Number 10400

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

Patient Problem Syncope/Fainting (4411)

Event Date 11/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that 10 minutes into a donation procedure, the donor began to feel uncomfortable (breathlessness and fainting).The procedure was immediately stopped.The donor was placed in the trendelenburg position on the donor couch.They then sent the donor to the hospital where he was given hydrocort (intravenous) (1 ampoule) and avil (intramuscular) (1 ampoule).The donor was sent home.The disposable set is not available for return because it was discarded by the customer this product is not available within the u.S., but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in h6 & h10.Dhr : a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: according to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.A disposable history search confirmed there were no similar occurrences reported on this lot worldwide.The relevant run data file (rdf) was analyzed for this event.Analysis of the rdf showed that optia 1p06606 is on version 11 software.A 10400 tubing kit was loaded successfully and passed the tubing set test.During ac prime an ¿air detected at ac sensor¿ alert was presented.The alert screen was cleared and the ac prime was completed without further alerts.Between 1.3 and the end of the procedure at 10 minutes, a ¿draw pressure too low¿ alert was presented 19 times and a ¿return pressure too high¿ alert occurred 5 times.Amongst these alerts, there were multiple ¿pumps paused for one minute¿ and ¿pumps paused for 3 minutes¿ alerts.The pause button was pressed five times.The procedure was aborted by the operator at 10 minutes from the last ¿pause button pressed¿ alert screen.Rinseback was not performed.During donor disconnect test, a ¿donor disconnect error¿ alert was displayed.No products were collected.It was confirmed that the trima accel system operated as intended and there were no unusual events.Root cause: a definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA PLATELET PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11046454
• MDR Text Key: 223716939
• Report Number: 1722028-2020-00555
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 10400
• Device Lot Number: 2003173130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00048 YR
• Patient Weight: 104