MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA COLLECT SET

Catalog Number 000000000000010120

Device Problems Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problem Blood Loss (2597)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

The customer reported that they received multiple alarms during a mononuclear cell (mnc) collection procedure.Approximately 3 hours into the procedure, there was a leak in the centrifuge.The procedure was ended without rinseback.Per the customer, almost no cells were collected and the attending physician ordered another collection be done on a different machine.The patient fluid balance was approximately +800 mls due to anti-coagulant.The customer also mentioned seeing some micro air bubbles in the return line during the original procedure.The patient is reported in stable condition.The customer declined to provide patient's identifier.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for injury has occurred.

Manufacturer Narrative

Investigation: the alarms experienced by the customer were a centrifuge pressure alarm 18 minutes into the procedure, at which time the lower bearing was found to be mis-loaded, and was then adjusted.Once the procedure continued, there were multiple 'interface took too long toe stablish' alarms along with some clumping issues per the terumo bct clinical specialist who was providing phone assistance during the procedure.When the 'leak detected' alarm occurred 3 hours into the procedure, the operator noted blood in the mesh part of the tubing set.Per the customer, it is possible the lower collar was not secured and the latching pin was not fully engaged.The disposable set was returned for investigation.Upon visual inspection, the lower loop sleeve was shredded and broken in the middle where the leak occurred.There was twisting of the loop sleeve near the lower bearing and one of the ears was sheared off.A mis-load of the lower bearing is the most likely root cause for this failure.The machine was functionally checked out at the customer site by a terumo bct service technician following the incident.The return line air detector functionality was verified and a autotest was performed.The machine was confirmed to be operating correctly.The run data file (rdf) was analyzed for this event.Based on the rdf the spectra optia operated as intended and is safe to use.The spectra optia system is designed to monitor the position of the interface throughout the run using the aim system.In this run, the aim system operated as intended by identifying that the interface was not in the expected position, possibly due to an inaccurate patient hct, obstructed collect or plasma line or an incorrectly loaded channel.The aim images were reviewed for this procedure and did not indicate severe enough platelet clumping in the channel and the collect port to cause these alarms.Based on the information available in the run data file, the system did detect air in the return lin however the accumulated amount of air that was detected was significantly less than the 1.0 ml required to trigger the return line air detector alarm.Air was visible at the return pressure senso due to the slower flow rates during the procedure; this caused the air to accumulate in the return pressure sensor but was never returned back to the patient.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A review of the lot for similar reports was carried out and none have been reported.Root cause: although a definitive root cause could not be determined, it is most likely a mis-loaded centrifuge loop collar that contributed to the resulting concerns during the procedure and ultimately, the leak in the centrifuge.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4152071
• MDR Text Key: 18364792
• Report Number: 1722028-2014-00403
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Catalogue Number: 000000000000010120
• Device Lot Number: 05W3220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2014
• 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): Other
• Patient Age: 00012 YR
• Patient Weight: 65