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

Model Number 10220

Device Problems Output Problem (3005); No Apparent Adverse Event (3189)

Patient Problems Electrolyte Imbalance (2196); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.Article citation: choi j, kim h, jun j, ryu j, lee hy.Recurrent pancreatitis in a pregnant woman with severe hypertriglyceridemia successfully managed by multiple plasmapheresis.Journal of atherosclerosis and thrombosis.2022; 29: 1108-1116.Http://doi.Org/10.5551/jat.62734.

Event Description

The journal article, 'recurrent pancreatitis in a pregnant woman with severe hypertriglyceridemia successfully managed by multiple plasmapheresis', describes a case study in which a 24-year-old pregnant woman was treated with plasmapheresis after suffering from recurrent pancreatitis related to hypertriglyceridemia.During the multiple sessions of plasmapheresis, supplemental calcium was administered only when the patient developed mild hypocalcemia symptoms.Other than a perioral tingling sense, the patient and the fetuses did not experience any significant complications during and after plasmapheresis.Patient identifier is not available at this time.The disposable set is not available for return for evaluation.

Event Description

The journal article, 'recurrent pancreatitis in a pregnant woman with severe hypertriglyceridemia successfully managed by multiple plasmapheresis', describes a case study in which a 24-year-old pregnant woman was treated with plasmapheresis after suffering from recurrent pancreatitis related to hypertriglyceridemia.During the multiple sessions of plasmapheresis, supplemental calcium was administered only when the patient developed mild hypocalcemia symptoms.Other than a perioral tingling sense, the patient and the fetuses did not experience any significant complications during and after plasmapheresis.Patient identifier is not available at this time.The disposable set is not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.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 determined that the citrate reaction was mild with preplanned over the counter oral calcium.No further reporting will be provided as this does not represent a reportable event.Article citation: choi j, kim h, jun j, ryu j, lee hy.Recurrent pancreatitis in a pregnant woman with severe hypertriglyceridemia successfully managed by multiple plasmapheresis.Journal of atherosclerosis and thrombosis.2022; 29: 1108-1116.Http://doi.Org/10.5551/jat.62734.

• 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: 15470746
• MDR Text Key: 302944649
• Report Number: 1722028-2022-00312
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 09/22/2022

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: 08/30/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• 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): Required Intervention; Other
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: Asian