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

Model Number 10220

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

Patient Problems Bacterial Infection (1735); Low Blood Pressure/ Hypotension (1914)

Event Date 08/19/2022

Event Type  Injury  

Event Description

The journal article, 'therapeutic plasma exchange: a potential therapeutic modality for critically ill adults with severe acute respiratory syndrome coronavirus 2 infection', describes a retrospective analysis on covid-19 patients admitted to the intensive care unit and treated with therapeutic plasma exchange (tpe) from april 17, 2020 to july 2, 2020.A total of 95 patients were included, among whom 47% (n = 45) received tpe.In terms of tpe safety in the cohort, decreased arterial blood pressure was reported in 4.1% (n = 5) of procedures, of which 3.0% (n = 4) required vasopressors support.Potential line related infections were detected in 13% (n = 6) of the patients.The article does not provide patient details, therefore this report is being submitted as a summary of events.The disposable sets are not available for return for evaluation.

Manufacturer Narrative

Lot number, expiry and manufacture dates are not available.Investigation is in process, a follow-up report will be provided.Article citation: al-hashami, sabria,khamis, faryal,al-yahyay, maha,al-dowaiki, samata,al-mashaykhi, louza,al-khalili, huda,chandwani, juhi,al-salmi, issa,al-zakwani, ibrahim (2022).Therapeutic plasma exchange: a potential therapeutic modality for critically ill adults with severe acute respiratory syndrome coronavirus 2 infection journal of clinical apheresis, n/a(n/a), e-pub, ahead of print.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 15625821
• MDR Text Key: 301935179
• Report Number: 1722028-2022-00343
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: MU
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2022

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 Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other