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

Model Number 61000

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, the staff member now wears goggle when performing procedures to avoid any further injuries.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that at the end of a procedure on a spectra optia device, a staff member reached around the back of the device to unplug the machine from the outlet, and since the space was limited, the staff member caught their eye on one of the hooks on the iv pole, cutting the eyelid.The staff member attended the emergency room (er) and stitches were required to the eyelid.They were taken off work duty for approximately 3 weeks.Following the absence, the staff member returned to work and is stable.The customer declined to provide the staff member weight.

Manufacturer Narrative

Investigation: the device serial number history report indicates no further related issues have been reported for this device.Review of the spectra optia operator's manual specifies a minimum clearance around the perimeter of the device of 30 cm (11.8 in).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 in h.6 and h.10.Investigation: a terumo bct service representative was sent on site to check out the device.The service representative confirmed there were no burrs or sharp edges on the iv hook.The device was a mobile unit, service representative was unable to confirm the clearance around the unit.There were no other issues identified with the device.Terumo bct informed the customer to advise all operators to ensure that the minimum clearance around the perimeter of the device of 30 cm (11.8 in) as specified in the operator¿s manual page 221, is observed when deciding where to place the machine for a procedure.Investigation is in process.A follo wup report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h6 and h.10.Root cause: the root cause for the reported incident was insufficient clearance around the device as specified in the operator's manual.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9266687
• MDR Text Key: 164643483
• Report Number: 1722028-2019-00327
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2019

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 01/03/2020; 04/27/2020; 07/10/2020
• Supplement Dates FDA Received: 01/10/2020; 05/01/2020; 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR