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

Catalog Number 000000000000010220

Device Problem Insufficient Information (3190)

Patient Problems Anaphylactic Shock (1703); Chest Pain (1776); Dyspnea (1816)

Event Date 01/06/2014

Event Type  Injury  

Event Description

The customer reported that a patient had an anaphylactic reaction to the last unit of fresh frozen plasma (ffp) during a therapeutic plasma exchange (tpe) procedure.During the procedure, the patient developed shortness of breath and chest pain.A medical code was called.The physician ordered 25 mg benadryl, 125 mg solumedrol, epinephrine im, and fluids via iv in response to the patient reaction.The patient was transferred to sicu briefly.The condition of the patient is now stable and she was discharged home.The customer declined to provide patient identifier.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to medical intervention in the form of breathing treatment, benadryl, solumedrol, epinephrine im.

Manufacturer Narrative

Investigation evaluation and corrective actions are in-process.A follow-up report will be provided.

Manufacturer Narrative

The disposable set was unavailable for return and investigation.The run data file was analyzed for this event.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The machine was checked out at the customer site by a terumo bct service technician.No issues were found during checkout.A saline run was completed without incident.Root cause: the kit was unavailable for specific root cause.The d logs did not indicate an abnormal procedure.The machine was evaluated and determined to be functioning as intended.Based on the spectra optia system functioning as intended and the customer's evaluation of the issue, the patient experienced an allergic reaction to the ffp.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, plasma replacement reactions may occur in approximately 7.8% of procedures, based on the results of a survey of therapeutic procedures.Of these reactions, most were mild and well tolerated.The spectra optia system has many safety features.A donor and/or patient reaction can occur rapidly, however.It is imperative that the operator continuously monitor the spectra optia system and the donor and/or patient.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which anevent occurred, but the type of reportable event was not indicated appropriately.This supplement is being filed to modify information to align with thereported event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3602407
• MDR Text Key: 19297644
• Report Number: 1722028-2014-00023
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2014

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: 11/01/2015
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 11V3127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 01/31/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/27/2014; 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2013
• 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; Required Intervention
• Patient Age: 00029 YR
• Patient Weight: 86