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

Model Number 61000

Device Problems Component Falling (1105); Component Missing (2306); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

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

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the device at the customer site and was able to replicate the issue.The technician inspected the spectra optia device and noticed a grub screw was missing from the iv pole.A replacement screw was fitted and tested in various positions.The iv pole now locks into place and functions correctly.The machine was returned to service.Investigation is still in process.A follow-up report will be provided.

Event Description

The customer reported that the iv pole on the optia equipment is unexpectedly lowering slowly and does not lock into the up position.No injury occurred with this event and the operator is fine.Patient information is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the last year of service history for this device indicated no other reports related to this issue.An internal report shows that the machine has been in use with no further occurrences of the problem.Root cause: the root cause of this failure was a missing grub screw.Correction: trima field action 30 has been initiated to notify all trima users to use precaution while transporting the device and a caution statement was included in the operator's manual.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.

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: 6251565
• MDR Text Key: 65232713
• Report Number: 1722028-2017-00007
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K113480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• 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: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other