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

Model Number	61000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device serial number and manufacture date are not available at this time.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that a staff member used a led flashlight to help with illumination while looking through the optia view port of the centrifuge.The led light reflecting back from the glass port, caught the staff¿ right eye, causing visual injury.Patient weight is unknown at this time.Per the customer the patient is seeing their md at this time and the outcome is unchanged.
Additional Manufacturer Narrative
Device serial number and manufacture date are not available at this time.Investigation: 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 stated that no medical intervention was provided to date.There is no evidence of medical intervention provided to reverse an issue with the eye or prevent further escalation of declining health.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer reported that a staff member used a led flashlight to help with illumination while looking through the optia view port of the centrifuge.The led light reflecting back from the glass port, caught the staff¿ right eye, causing visual injury.Patient weight is unknown at this time.Per the customer the patient is seeing their md at this time and the outcome is unchanged.No medical intervention was required to date.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 12656765
• Report Number: 1722028-2021-00328
• Device Sequence Number: 3750505
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BK150251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male