MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a thrombotic microangiopathy patient was undergoing a therapeutic plasma exchange (tpe) procedure.During the procedure, they received an ¿aim failure¿ alarm.The operator was unable to resolve the alarm at the time, so he was left with the only option to discontinue the procedure.On the following morning ((b)(6) 2018) the patient was transported by a helicopter to another hospital.It is unknown at this time if the patient required medical intervention.Patient identifier and weight are not available at this time.

Manufacturer Narrative

A terumo bct service technician visually inspected the machine at the customer's site and was able to confirmed the reported aim subsystem alarm.Upon inspection, the technician discovered a bad electrical connection in the ebox and performed are alignment.A preventive maintenance (pm) was also performed per manufacturer's specification.The device serial number history report indicates no further related issues have been reported for this device.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: one year of service history was reviewed for this device with no issues related to the reported condition identified.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: during follow-up with the customer, it was confirmed that the patient was transferred to another hospital to have tpe procedures performed there.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that no medical intervention occured due to device failure as the procedure was never started.During investigation is was determined that the device failed safe with an alarm that would not allow the procedure to occur.Root cause: the root cause of the reported condition was faulty circuit card connections within the e-box.

Event Description

Per the customer, the patient is now ok, left the hospital and went back home.Due to eu personal data protection laws, the patient id and weight are not available from the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7377989
• MDR Text Key: 103730042
• Report Number: 1722028-2018-00079
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2018

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 Model Number: 61000
• Other Device ID Number: 05020583610002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/03/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 04/04/2018; 07/17/2018; 07/24/2018
• Supplement Dates FDA Received: 04/20/2018; 07/17/2018; 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2007
• 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: 00032 YR