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

Catalog Number 10310

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 11/26/2014

Event Type  malfunction  

Manufacturer Narrative

Article:lisenko, k., et.Al.(2016).Comparison between intermittent and continuous spectra optialeukapheresis systems for autologous peripheral blood stem cell collection.'journal of clinical apheresis'.Doi 10.1002/jcainvestigation is in progress.A follow-up report will be provided.

Event Description

During a terumo bct review of the journal of clinical apheresis doi 10.1002/jca, an event regarding recurrent clotting in the collection set was found.A continuous mononuclear (cmnc)collection had to be interrupted and a new set was loaded before continuing the procedure due to the clotting.There was no indication in the article of where in the set the clot was located.Per the article, it was suggested that the patient might have a pre-existing hypercoagulopathy condition, but further diagnostics did not confirm the condition.In the following two days, the collection process was completed with two more leukapheresis sessions without complications.Details about this incident such as, date of incident, lot and serial number or collection information are not available at this time.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable set is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the customer, clotting was observed on the connection site and the patient did not require a follow-up visit.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.Clarification of the incident was received from the customer and confirmed that there was no clotting in the return line.Investigation is in progress.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The event description and rdf are consistent with an obstruction in the inlet line trap.Interface images in the channel showed some immediate signs of clumping during the procedure.The inlet:ac ratio was not adjusted throughout the procedure.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.Root cause: based on the rdf analysis the root cause for the incident is inadequate ac management.

Event Description

Patient gender and weight were obtained from the run date file (rdf).

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5661071
• MDR Text Key: 45987883
• Report Number: 1722028-2016-00307
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: BK140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2016

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: 08/01/2016
• Device Catalogue Number: 10310
• Device Lot Number: 08W3128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/10/2016; 07/22/2016; 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• 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 Weight: 70