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

Catalog Number 000000000000010120

Device Problems Device Alarm System (1012); Clumping in Device or Device Ingredient (1095); Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

The customer reported that they had a patient that was mobilized with mozobil and gmobilization for a stem cell collection and they only achieved half of the expected yield of 2.36 instead of 5.1.During the procedure, the ac ratio was adjusted from 8 to 9 since clumping wasobserved in the collect line towards the reservoir, but no clumping was observed in theconnector.No alarms were indicated by the machine.Per the customer, the leukoreduction(lrs) chamber was pink in color and the product color was lighter than the chamber.It is unknown at this time if the patient required remobilization for the second collection.Patient information is unavailable at this time.Patient outcome is unavailable at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

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 there is a likely potential for death or serious injury associated with this event based on the additional investigational information.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Based on the run data file analysis, the spectra optia system operated as intended.Review of the aim images revealed that some buffy coat was present throughout the run.Root cause: a definitive root cause for the lower than expected yield could not be determined.Possible causes include, but are not limited to, buffy coat accumulation, which can occur when patient¿s wbc and platelet counts are high, and many pauses throughout the run.

Event Description

The customer declined to provide patient identifier.Per the customer, the patient had a follow-up visit with her oncologist on and is 'fine'.

Manufacturer Narrative

The customer stated that the patient was not remobilized due to the lower than expected yield.

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: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4889366
• MDR Text Key: 16310005
• Report Number: 1722028-2015-00243
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140151
• 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: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 000000000000010120
• Device Lot Number: 05Y3212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/24/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• 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: 00043 YR
• Patient Weight: 59