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

Model Number 61000

Device Problems No Flow (2991); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Serial number and manufacture date information are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient experienced an adverse event during a procedure on a spectra optia device.Per the customer, the apheresis nurse was not able to return the blood to the patient mid-treatment.It is unknown if medical intervention was required for this event.Patient information and outcome are unknown at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a terumo bct service technician checked out the machine at the customer site.Field action 32 was successfully completed per manufacturer instructions.The pump driver, cca was replaced.Root cause: since the replacement of the pump driver, cca has resolved the issue, it is likely that this part was defective or a contributing factor.

Manufacturer Narrative

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.The amount of blood that could not be returned to the patient would not have led to a final fluid balance that is below 80% and no medical intervention was required for the event.During follow-up with the customer, it was reported that the optia equipment at this location did receive service following the event.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.This event was determined to be not reportable.Correction: spectra optia field action 32 has been initiated to notify all spectra optia users of a potential safety hazard.An alarm rate in optia gen 2 e-boxes for when the low-level sensor sees air and the safety computer sees the return pump still rotating in the direction of the patient.A customer letter will be sent to affected customers notifying them of the situation.Field action 32 was successfully completed on 12/06/2019.Investigation is in process.A follow up report will be provided.

Event Description

During follow-up with the customer, it was reported that the patient lost >100ml of blood and they were unable to reinfuse the patient and the treatment was ended.No medical intervention occurred as a result of this adverse event.The customer reported receiving a "return pump did not stop when it should have" alarm for this event.The customer declined to provide the patient identifier and patient outcome.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9526295
• MDR Text Key: 177603100
• Report Number: 1722028-2019-00448
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• PMA/PMN Number: K181049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/24/2020; 02/26/2020
• Supplement Dates FDA Received: 02/14/2020; 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00073 YR
• Patient Weight: 125