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

Catalog Number 000000000000010220

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

Patient Problem Reaction (2414)

Event Date 11/19/2014

Event Type  Injury  

Event Description

The customer reported that a patient was undergoing a red blood cell exchange (rbcx)procedure and had a transfusion reaction.The rbcs were used as replacement fluid.During mid procedure, the patient developed hives.Per physician's order, benadryl and steroids were administered to the patient.The patient did not require a follow-up visit and was released the same day.The patient is reported in stable condition.Patient identifier is not available at this time.The customer declined to provide patient's weight.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 benadryl and steroids.

Manufacturer Narrative

Investigation: per ther customer, fluids used: 846 ml of rbc's, saline 0.9% and acd-investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to the reaction the patient experienced.The run data file (rdf) was analyzed for this event.Signals in the run data file show that the spectra optia system operated as intended.There is no indication of what may have caused the patient to develop a transfusion reaction during the procedure.The spectra optia apheresis system essentials guide provides the following procedural caution and suggestions to the operator with respect to a patient reaction: the spectra optia system has many safety features.However, a patient reaction can occur rapidly.Therefore, it is imperative that the operator monitor the patient and the system throughout the procedure.In a study referred to within the therapeutics apheresis: a physician¿s handbook, 10% of the procedures experienced a reaction during erythrocytapheresis and 1.6% experienced transfusion reactions.Of the recorded reactions, most were minor and well tolerated.Root cause: based on information provided by the customer and the machine¿s data analysis, the patient¿s transfusion reaction was caused by the rbc product.

Event Description

The customer declined to provide patient identifier.The patient's weight was obtained form the run data file analysis (rdf).

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• 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: 4358543
• MDR Text Key: 5180332
• Report Number: 1722028-2014-00517
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140151
• 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: 12/03/2014

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: 11/01/2016
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 11W3205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/16/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00017 YR
• Patient Weight: 55