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

Catalog Number 10200

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

Patient Problems Dyspnea (1816); Nausea (1970); Vomiting (2144)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: per the customer, the patient was also receiving calcium 4gm ivpb as an additional planned treatment during the procedure.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure, the patient had nausea and began vomiting bilious fluid for 5 minutes.The procedure was paused and the primary rn was notified.The patient then complained of difficulty breathing for about 2 minutes.Lungs were clear and o2 saturation was 99%.The patient was seen by the hospitalist.Zofran 4mg was given, a chest x-ray was ordered and done, and the patient was ok to proceed with the procedure per the md.The patient refused to restart the treatment due to severe nausea.The doctor was notified and rinseback was done with no further vomiting.Patient was alert and oriented x3 throughout with elevated blood pressure.Post procedure, the patient ambulated to the bathroom with minimal assist.Nausea persisted.Patient identifier and age are not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions dhr : the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged vasovagal reaction include but are not limited to patient disease state and/or patient sensitivity to the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET, EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11046814
• MDR Text Key: 223606077
• Report Number: 1722028-2020-00558
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

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 Catalogue Number: 10200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 02/02/2021; 02/11/2021
• Supplement Dates FDA Received: 02/04/2021; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00046 YR
• Patient Weight: 112