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

Model Number 61000

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

Initial reporter full email: (b)(6) evaluation method code data validation investigation: per the customer, they suspected the bubbles in the return line past the reservoir,were coming from the inlet line.They considered changing the inlet access but were informed by the lab that the target had been achieved so they decided to do rinseback and end the procedure.The machine was checked out at the customer site by a terumo bct service technician.A full autotest and saline run were performed with no issues found.The run data file (rdf) was analyzed for this event.Signals in the run data file showed that the spectra optia system operated as intended.The return line air detector is constantly monitoring the return line for air and if it is detected, the system will pause the pumps, the alarm ¿air was detected in return line¿ occurs, and the system will display instructions for removing the air.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 30 minutes prior to the end of a mononuclear cell(mnc) collection procedure, the rn noticed air in the reservoir that advanced to the return line and was returned to the patient.The rn ended the procedure with rinseback.The customer stated that she noticed micro bubbles in the return and inlet line during rinseback and there were no return line alarms.The patient was not affected and had no symptoms, he was discharged from the customer's care.The patient is reported in stable condition.The customer followed up with the patient the next day and he was 'ok'.The customer declined to provide the patient identifier.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a preventive maintenance (pm) was successfully performed.During service, it was verified that the return line air detector was functioning properly.An internal report indicates no further related issues have been reported for this device.Root cause: the root cause of the reported air returned to donor could not be determined atthis time.The run data files indicate that the system operated as intended.

Manufacturer Narrative

The rlad is designed to detect air based on the threshold for the patient.If the air is lower than the threshold for the patient, the rlad will not alarm.In this case the patient did not show any symptoms of air at the time of the incident.Follow up with the patient was done on august 14, 2015 and no issues were reported.The amount of air received by the patient was most likely less than the air threshold for the patient, which is why the rlad did not alarm.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information in and to align with the reported event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5058155
• MDR Text Key: 25511764
• Report Number: 1722028-2015-00514
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK140151
• 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: Followup,Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2015
• 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: 00051 YR
• Patient Weight: 82