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

Catalog Number 10220

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

Patient Problem Viral Infection (2248)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a patient underwent a procedure on spectra optia.It was later found that the patient had contracted creutzfeldt-jakob disease (cjd).Per the customer, they contacted terumo bct to confirm that the patient's blood does not come in contact with the spectra optia device and they reported they do not believe that the optia device was the cause of the patient contracting cjd.The customer declined to provide patient information.The spectra optia exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer reported the incident because documentation to the sterility of the set and the closed nature of the set was needed for the customer's internal purposes.The customer is not alleging a deficiency with the device or the disposable.There is no evidence of a device malfunction.Blood does not come into contact with the machine.The customer provided 3 possible lot numbers that were used on 4 different machines, therefore, it is not known which lot number was used on which device.Based on this information, a dhr review was performed for all 3 lots indicated by the customer.The dhr review did not reveal any anomalies that would have contributed to this incident.This record will reflect the investigation for lot number 1801233230.Please refer to mdrs; 1722028-2018-00125, 1722028-2018-00126 and 1722028-2018-00127 which address the 3 remaining optia machines.The spectra optia disposable set was not available for return.The attached scientific journal discusses the nature of (b)(6) disease.Per internal medical review, it is concluded, the risk of a patient acquiring the tse pathogen that causes (b)(6) infection is minimal when they undergo a therapeutic procedure using the spectra optia therapeutic apheresis system.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to:- contamination in the transfused plasma- unknown patient exposure route to prions.

Event Description

The customer declined to provide patient outcome, if medical intervention was required, the patient stats or any further procedural details.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: per the customer's request, a certificate of compliance for lot # 1801233230 was provided to the customer to ensure sterility of the product.Investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7508361
• MDR Text Key: 108095052
• Report Number: 1722028-2018-00128
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

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: 01/01/2020
• Device Catalogue Number: 10220
• Device Lot Number: 1801233230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 10/01/2018
• Supplement Dates FDA Received: 07/23/2018; 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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