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 Problems Bruise/Contusion (1754); Fall (1848); Loss of consciousness (2418)

Event Date 10/08/2014

Event Type  Injury  

Event Description

The customer reported that a patient underwent a red blood cell exchange (rbcx) procedure.After discharge from the unit, the patient fainted on the way home.The patient had some facial bruising and scrapes and was unsure if he hit his head.Patient was seen in the emergency department and received a head ct scan and admitted overnight for observation.Per the customer, the patient completed the procedure with no complications and the patient was observed by the nursing staff for approximately 20 minutes post procedure.The patient is instable condition and did not require follow-up.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 head ct and overnight hospitalization.

Manufacturer Narrative

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.Based on the information available in the run data file, the spectra optia system operated as intended.There is no indication in the run data file of a clear root cause for the patient fainting following the procedure.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, first time procedure patients reactions may occur in approximately 4.8% of procedures, and 1.2% of procedure patients experience reactions to citrate, 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.However, a patient reaction can occur rapidly.Therefore, it is imperative that the operator continuously monitor the patient and the system throughout the procedure.Root cause: this disposable set was unavailable for specific root cause analysis.Based on information provided by the customer, it is possible that the patient exhibited an allergic reaction to acd-a and/or eto.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury of the mdr form.This supplement is being filed to modify information per fda request.

• 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: 4224939
• MDR Text Key: 19802904
• Report Number: 1722028-2014-00438
• 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: 10/10/2014

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: 09/01/2016
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 09W3117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2015; 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• 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): Hospitalization
• Patient Age: 18 YR
• Patient Weight: 63