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

Catalog Number 12220

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

Patient Problems Dizziness (2194); Pallor (2468)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a patient reaction that occurred during a therapeutic plasma exchange (tpe) procedure on a spectra optia device.The patient complained of hives, dizzy, lightheaded, pallor, short of breath.The attending physician decided to abort the procedure and ordered 50 mg of benadryl by iv.Per the customer, the patient recovered.He was inpatient and remained inpatient.Calcium gluconate was administered prior to the procedure at a rate of 25mg/kg/hr for the duration of the procedure for a total of 4923mg.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h6 & h10.Investigation: per the customer, the same patient underwent another tpe procedure earlier on march 2nd and became short of breath, diaphoretic, pale, and fainted.He was given oxygen (15 l per min non rebreather) and recovered.He was inpatient and remained inpatient.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.The disposable lot query was performed for lot 2011033130 and no similar reported occurrences were received against this lot to date.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the patient's reaction include but are not limited to - ac management during the procedure, - the length of the procedure and/or patient sensitivity to anticoagulant, ethylene oxide used to sterilize the disposable set - an allergy to replacement solution.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11575295
• MDR Text Key: 242670680
• Report Number: 1722028-2021-00131
• 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): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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 Expiration Date: 11/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2011033130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00019 YR
• Patient Weight: 85