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

Model Number 61000

Device Problems Air Leak (1008); Mechanical Problem (1384); Occlusion Within Device (1423); Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician visually inspected the machine at the customer's site and verified the reported condition.The technician found that return line air detector (rlad) was defective and failed to detect the presence of fluid in the return tubing.The service technician replaced the rlad assembly, successfully performed an autotest and a saline run and verified that system is fully operational after the repair.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported an 'air was detected in return line' alarm.Due to eu personal data protection laws, the patient (donor) information and outcome is not available from the customer.

Manufacturer Narrative

This record 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.It was determined that the alarm, failure of the fluid presence check by the air sensor of the return tubing, is a fail safe alarm.During follow-up with the service technician it was reported that they had the alarm during the prime of the set and the sensor detected always air even if the kit was wet.One year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.Preventive maintenance was performed on 06/16/2018 and the device was verified to be operating per manufacturer specifications.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

No patient (donor) was connected at the time of the event.

• 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: 7606134
• MDR Text Key: 112167202
• Report Number: 1722028-2018-00178
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K103090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other