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

Model Number 61000

Device Problems Component Falling (1105); Positioning Failure (1158)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

A terumo bct technician checked out the machine at the customer site and was able to duplicate the reported condition.The technician inspected the spectra optia machine and noted that the iv pole actuator needed adjustment.The iv pole actuator was adjusted and it was verified that the pole was secure in all positions.The machine was returned to service.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the iv pole on the spectra optia equipment would not engage properly.Information of patient (donor) or operator of the device is not known at this time.Outcome of patient (donor) or operator of the device is not known at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: per the customer, the iv pole does not move unless the button is depressed because the iv pole will still lock in place properly on the right side.

Event Description

The customer reported that the iv pole on the spectra optia equipment would not engage properly.While troubleshooting, they found that when fully extended, the iv pole would not lock into place on the left side.No injury was reported for this incident and no patient was connected at the time the iv pole was not properly engaging.Therefore, no patient information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information.Correction: a optia field action has been initiated to notify all optia users to use precaution while transporting the device and a caution statement was included in the operator's manual.

Manufacturer Narrative

This report is being filed to provide additional information.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: an internal report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no problems identified related to the reported condition.Root cause: the root cause of this failure was a mis-adjusted iv pole actuator.

Manufacturer Narrative

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

• 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: 6547410
• MDR Text Key: 74658328
• Report Number: 1722028-2017-00171
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2009
• 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