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

Model Number 61000

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician visually inspected the machine at the customer's site and was unable to duplicate the reported condition.The service technician verified that the door locking mechanism is functioning properly.An autotest and saline run were successfully performed.The device serial number history 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.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the centrifuge door would not stay closed during a procedure.Per the customer, they had to tape the door shut to complete the procedure.Patient information and outcome are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the root cause of this failure was undetermined.

Event Description

Per the customer, no injuries occurred to the patient (donor) and operator.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

No injury was reported for this incident and no patient/donor was connected at the time of the reported event, therefore no patient/donor information is reasonably known.

Manufacturer Narrative

This report is being filed to correct information that was provided in the initial mdr.

• 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: 7100233
• MDR Text Key: 95868762
• Report Number: 1722028-2017-00471
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2017

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 12/22/2017; 01/08/2018; 11/10/2017
• Supplement Dates FDA Received: 12/28/2017; 01/19/2018; 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other