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

Model Number 10220

Device Problem Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/30/2022

Event Type  Injury  

Event Description

The journal article, 'therapeutic plasma exchange for myasthenia gravis, guillain-barre syndrome, and other immune-mediated neurological diseases, over a 40-year experience' describes a study of therapeutic plasma exchange (tpe) used in myasthenia gravis (mg) and guillain-barré syndrome (gbs).The study was done of patients undergoing tpe for neurological diseases from 1981 to 2020.159 patients (48.69 ±18.15 years, 54.3% females) underwent tpe using central-venous catheter and replacement fluid albumin.Complication rate was low (3.9% procedures), mostly hypotensive/vasovagal reactions (55.3%) and vascular access-related complications (38.3%).Most were mild-moderate (92.9%), permitting tpe completion, and somewhat more frequent during the first procedure (38.3%) and after periods of little tpe use.Gbs patients were more prone to complications than mg patients (6.5% vs.1.2%,p<0.001) mainly hypotensive/vasovagal reactions (3.7% vs.1.0%,p=0.008).Regarding these adverse events (aes), in total out of the 1207 procedures, complications were recorded in only 47 cases (3.9% of all procedures).In only 9 cases were two different aes recorded in the same procedure, being a combination of problems with vascular access, hypotensive/vasovagal symptoms and/or paresthesia.A total of 31 patients (19.5%) suffered some kind of ae, however most (92.9%) were mild to moderate and tpe could be completed.In fact, 5 of the 31 patients (16.1%) who suffered some kind of ae were treated a second and/or third time with tpe.Only in 3 cases was tpe stopped due to complication of tpe, this being catheter infection with secondary sepsis, which was successfully treated with antibiotics.For one patient with aie, tpe had to be suspended due to agitation.Of note, in three cases tpe was suspended after the first 2¿3 procedures due to change in presumed diagnosis after tpe initiation.Two patients with mg suffered trouble breathing whilst tpe was being performed but this did not lead to tpe suspension.Patient information or medical intervention details were not provided in the article, therefore this report is being filed as a summary of events.The exchange sets are not available for return for evaluation.

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: fernández-fournier, m.,kerguelen, a.,rodríguez de rivera, f.J.,lacruz, l.,jimeno, s.,losantos, i.,hernández-maraver, d.,puertas, i.,tallon-barranco, a.,viejo, a.,frank garcía, a.,díez-tejedor, e.2022.Therapeutic plasma exchange for myasthenia gravis, guillain-barre syndrome, and other immune-mediated neurological diseases, over a 40-year experience.Expert review of neurotherapeutics.2022.22:897-903.Investigation is in process.A follow up report will be provided.

• 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: 16585193
• MDR Text Key: 311739223
• Report Number: 1722028-2023-00110
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/21/2023

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: 02/25/2023
• Initial Date FDA Received: 03/21/2023
• 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