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

Catalog Number 10120

Device Problem Shelf Life Exceeded (1567)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they had used a disposable set that had expired july 2015.The expiration date was discovered at the beginning of the mononuclear cell (mnc) collection procedure and less than 10mls had been collected.The physician was notified, rinseback was performed, and the product was discarded.No adverse reaction occurred and the patient is in stable condition.Patient information is not available at this time.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the root cause for the use of an expired set was due to operator error.Terumo bct clinical support specialist followed up with the customer, regarding this incident to explain that expiration dates are based on aging studies performed.Products are only validated to their expiration date.

Event Description

The customer declined to provide the patient's information.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5347370
• MDR Text Key: 35549110
• Report Number: 1722028-2016-00002
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

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 Catalogue Number: 10120
• Device Lot Number: 07V3122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other