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

Model Number 61000

Device Problems Fire (1245); Self-Activation or Keying (1557); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician visually inspected the machine at the customer site.Upon inspection, it was found that the machine alarmed aim subsystem failed and stccca was found to be burned out and the fire wire cca was damaged by the fire from it.The service technician replaced the firewire cca and stc cca.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that following a successful platelet procedure with no issues noted on the optia machine, the machine was left switched on for 2 hours.When the staff returned to the area, they reported smelling fire coming from the machine and the machine repeated restart.It is unknown at this time if there was an injury or if medical intervention was required for this event.Operator or patient information and outcome are not available at this time.

Manufacturer Narrative

Investigation: the spectra optia's firewire cca and stc cca were returned to terumo bct for evaluation.The service technician could not duplicate the reported condition with firewire cca but was able to duplicate the reported issue with stc cca.No functional problem is found with the firewire cca.The service technician found stc cca to be damaged with burned u6 possibly due to shorted c10.The device serial number history report indicates no further related issues have been reported for this device.The device history report (dhr) and service history were reviewed for this device with no issues related to the reported condition identified.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that no injuries occured to the patient or operators for this specific event.The event occured 2 hours after patient disconnect.The machine was left switched on, when the customer returned to the machine they smelled fire and the optia kept restarting.

Manufacturer Narrative

This report is being filed to provide corrected information.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

The root cause of this failure was a shorted polaraized capacitor on the stccca.

Event Description

Due to eu personal data protection laws, the patient information is 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: 7584120
• MDR Text Key: 111043650
• Report Number: 1722028-2018-00162
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Other Device ID Number: 05020583610002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 06/29/2018; 07/24/2018; 08/06/2018
• Supplement Dates FDA Received: 07/03/2018; 07/25/2018; 08/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• 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