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

Catalog Number 12220

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

Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that 1-2 hours after an spd procedure, the patient experienced oxygen de-saturation requiring diuresis and increase in ventilator settings due to fluids received from the procedure.The attending doctor ordered furosemide (lasix) iv.Prior to the procedure the patient was in critical condition with respiratory failure, ventilated and on ecmo due to covid-19 infection.Per the customer, the patient had difficulties tolerating positive fluid balance (per normal operation of the procedure) as this is the nature of spd.There was no indication of procedural issues and the procedure was performed as expected.Per the doctor, the patient was stable post medical intervention and is now recovering from the infection.Patient information is not available because this was an spd save study patient.The disposable set is not available for return because the customer was able to continue the procedure.

Manufacturer Narrative

This report is being filed to provide additional information in h10.Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h6 and h10.Investigation: infection with the new coronavirus (severe acute respiratory syndrome coronavirus 2, or sars-cov-2) causes coronavirus disease 2019 (covid-19).Although most people with covid-19 have mild to moderate symptoms, the disease can cause severe medical complications and lead to death in some people.Older adults or people with existing chronic medical conditions are at greater risk of becoming seriously ill with covid-19.Complications can include: - pneumonia and trouble breathing - organ failure in several organs - heart problems - acute respiratory distress syndrome - blood clots - acute kidney injury - additional viral and bacterial infections root cause: based on information provided by the physician, the patients required medical intervention due to oxygen de-saturation which was caused by covid-19 related respiratory failure.In addition, the patients were given lasix (a diuretic) following the plasma treatments.It is common for patients to be hypervolemic at the end of tpe spd procedures because they receive all of the acd-a used for the run in addition to their plasma.The rinseback steps further increase the volume the patient receives during the procedure and physicians have the option to determine whether rinseback should be performed, the plasma device should be rinsed, and the contents of the treated plasma bag should be returned.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10245160
• MDR Text Key: 198076697
• Report Number: 1722028-2020-00323
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2020

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 Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 10/23/2020; 11/16/2020
• Supplement Dates FDA Received: 10/29/2020; 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention