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

Model Number 61000

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

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

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation:the machine was checked out by terumo bct service and the diffuser plate was found to be dirty from previous set leakages.The diffuser plate and interface parts were cleaned.An autotest and an interface system test were conducted, before returning the machine to service.Investigation is in progress.A follow-up report will be provided.

Event Description

The customer reported that medical intervention was necessary following a mononuclear cell(mnc) collection procedure.During the procedure, they received several "red blood cells were detected too soon" and "red blood cells were detected before system predicted chamber was full" alarms.Details regarding the medical intervention that was necessary are not available atthis time.Patient information and outcome are not available at this time.

Manufacturer Narrative

Investigation: follow-up with the customer was done regarding the reported medical intervention.Per the customer, an autologous stem cell collection to be used for transplant was ordered by the physician.It is not known at this time if the stem cell collection was in response to the event, or was referring to the procedure that was being performed at the time of the reported event.Clarification has been requested.Investigation is in progress.A follow-up report will be provided.

Manufacturer Narrative

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 with the customer has clarified that the stem cell collection for transplant that they reported as medical intervention was the actual stem cell collection that was performed.No further medical intervention was reported.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: one year of service history was reviewed for this device with no problems identified related to the reported condition.The run data file (rdf) was analyzed for this event.Analysis of the rdf and associated interface management images for this procedure suggests the lights used to illuminate the connector in the centrifuge may have been too bright resulting in excess rbcs entering the collect line and into the chamber.Overly bright lighting causes the light to be diffused around the collect port making the contents in the collect port appear lighter to the aim system than they actually are.Consequently, the system will try to darken the collection to achieve the targeted cp because it"thinks" the contents are too light.This can then result in rbcs entering the chamber.Data from the rbc detector indicated the concentration of cells flowing through the collect port was higher than what is expected for mnc procedures.Receiving the ¿red blood cells were detected too soon¿ alarm during the procedure indicates excess rbcs entering the chamber.If the aim system does not see a crisp delineation of the collect port, it calculates it as being lighter than it actually is and causes the system to collect a darker than desired product.Common causes of bright/diffuse lighting include bright strobe lights, or a film or dirt on any of the aim system camera or lighting components including the diffuser plate.Root cause: the root cause of this failure was most likely the lights used to illuminate the connector in the centrifuge may have been too bright and the dirty diffuser plate.There are no safety issues with the reported condition.The device failed safe as designed.

Event Description

Due to the personal data protection laws with the oman health authorities, the patient information is not available from the customer.Patient's gender and weight were obtained from the run data file (rdf).

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5787748
• MDR Text Key: 49375850
• Report Number: 1722028-2016-00412
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/29/2016; 09/22/2016; 10/14/2016; 11/08/2016; 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2014
• 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): Required Intervention
• Patient Weight: 76