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

Model Number 61000

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that while performing a mononuclear cell (mnc) collection procedure on spectra optia, they received a 'return line air detector failed' alarm during prime.Per the customer, the set was unloaded and a new set was used to continue the procedure.Patient information and outcome are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.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.Follow up information indicated that the device presented a fail safe alarm.A terumo bct service technician checked out the machine at the customer site and a repair and preventative maintenance (pm) was performed.The rlad was found to be intermittent fault and was replaced.The pm was completed per manufacturer instructions.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 one issue related to the reported condition identified.The customer reported that the device alarmed 'return line air detector failed fluid check'.No service was involved for the reported condition as the device failed safe.Root cause: since the replacement of the return line air detector has resolved the issue, it is likely that this part was defective or a contributing factor.

Event Description

During follow-up it was determined that the alarm that occured for this event was return line air detector failed fluid check.Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.

Event Description

The customer declined to provide the patient id, weight and outcome.

• 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: 7715448
• MDR Text Key: 115274875
• Report Number: 1722028-2018-00198
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: BK120076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/06/2018; 09/06/2018
• Supplement Dates FDA Received: 08/17/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2013
• 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
• Patient Age: 31 MO