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

Model Number 10220

Device Problem Insufficient Information (3190)

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

Event Date 10/31/2021

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: swaroop s, arora u, biswas s, et al.Therapeutic plasma-exchange improves short-term, but not long-term, outcomes in patients with acute-on-chronic liver failure: a propensity score-matched analysis.J clin apher.2022;1-14.Doi:10.1002/jca.22033 investigation is in process.A follow up report will be provided.

Event Description

The article, 'therapeutic plasma-exchange improves short-term, but not long-term, outcomes in adult patients with acute-on-chronic liver failure: a propensity score-matched analysis', describes a study of "the" impact of therapeutic plasma exchange (tpe) on patients with acute-on-chronic liver failure (aclf).A total of 1151 patients (aclf n = 864 [75%], ad [without organ failure] n = 287 [25%]) were included.Thirty-nine patients received tpe and standard medical treatment.Post-tpe procedure, each patient was observed for 1-2 hours for immediate post procedure complications.Hypotension (8, 20.5%) and new infections (17, 43.5%) which included hospital-acquired pneumonia, urinary tract infections and bacteremia were the most common complications.Patient details were not provided in the article, therefore this report is being submitted as a summary of events.The apheresis sets are not available for return for evaluation.

• 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: 16131996
• MDR Text Key: 307016474
• Report Number: 1722028-2023-00011
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial
• Report Date: 01/10/2023

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: 12/21/2022
• Initial Date FDA Received: 01/10/2023
• 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