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

Model Number 10220

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Viral Infection (2248); Fungal Infection (2419)

Event Date 08/13/2022

Event Type  Injury  

Event Description

The article, 'a comparison of methods of plasmapheresis for the treatment of late antibody mediated rejection in kidney transplant recipients' describes a study that compared the outcomes associated with plasma exchange (pe), double filtration plasmapheresis (dfpp), or immunoadsorption (ia) in the treatment of late antibody mediated rejection (amr) in 69 kidney transplant recipients.Recipients with late amr were retrospectively categorized according to management with pe (n = 30), dfpp (n = 22) or ia (n = 17).Pe and ia treatments were performed using spectra optia.Dfpp was performed using device not manufactured by terumo bct.No major adverse events were attributed to the interventions.All patients tolerated the treatment regimens well, there were no life-threatening allergic reactions.During follow-up, cmv disease or viremia developed in four patients (two patients in pe, one patient in dfpp, one patient in ia groups, p = 0.95).Bacterial or fungal infections developed in sixteen patients (23.2%) in total [eight patients (26.6%) in pe, four patients (18.2%) in dfpp, four patients (23.5%) in ia groups, p = 0.77].Mild to moderate pneumonia and urinary tract infections were seen in fifteen patients, and one patient in pe group had necrotizing fasciitis.Medical intervention or outcomes from adverse effects were not discussed in the article.Patient information is not provided in the article, therefore this report is being filed as a summary of events.The devices are not available for return for evlauation.

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: caliskan y, mirioglu s, dirim ab, ozluk y, yegit o, aksoy e, et al.A comparison of methods of plasmapheresis for the treatment of late antibody mediated rejection in kidney transplant recipients.Therapeutic apheresis and dialysis.2022.Https://doi.Org/10.1111/1744-9987.13937 investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that all the patients received immunosuppression drugs and the timing of these adverse reactions suggest that they are not related to the pe treatment.In addition, the authors did not allege any device malfunction or causality.No further reporting will be provided as this does not represent a reportable event.Lot number and expiry are not available at this time.Article citation: caliskan y, mirioglu s, dirim ab, ozluk y, yegit o, aksoy e, et al.A comparison of methods of plasmapheresis for the treatment of late antibody mediated rejection in kidney transplant recipients.Therapeutic apheresis and dialysis.2022.Https://doi.Org/10.1111/1744-9987.13937.

Event Description

The article, 'a comparison of methods of plasmapheresis for the treatment of late antibody mediated rejection in kidney transplant recipients' describes a study that compared the outcomes associated with plasma exchange (pe), double filtration plasmapheresis (dfpp), or immunoadsorption (ia) in the treatment of late antibody mediated rejection (amr) in 69 kidney transplant recipients.Recipients with late amr were retrospectively categorized according to management with pe (n = 30), dfpp (n = 22) or ia (n = 17).Pe and ia treatments were performed using spectra optia.Dfpp was performed using device not manufactured by terumo bct.No major adverse events were attributed to the interventions.All patients tolerated the treatment regimens well, there were no life-threatening allergic reactions.During follow-up, cmv disease or viremia developed in four patients (two patients in pe, one patient in dfpp, one patient in ia groups, p = 0.95).Bacterial or fungal infections developed in sixteen patients (23.2%) in total [eight patients (26.6%) in pe, four patients (18.2%) in dfpp, four patients (23.5%) in ia groups, p = 0.77].Mild to moderate pneumonia and urinary tract infections were seen in fifteen patients, and one patient in pe group had necrotizing fasciitis.Medical intervention or outcomes from adverse effects were not discussed in the article.Patient information is not provided in the article, therefore this report is being filed as a summary of events.The devices are not available for return for evlauation.

• 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: 15988446
• MDR Text Key: 305540796
• Report Number: 1722028-2022-00407
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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: 11/22/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/15/2023
• 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