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

Catalog Number 10116

Device Problems Misassembled (1398); Occlusion Within Device (1423)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: a photograph of the set was submitted by the customer.Upon photographic inspection, it was confirmed that the sterile filter was misassembled and air bubbles were noted in the return saline line.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during prime for a collection procedure, the operator noted air inthe saline line.The operator stopped and ended the procedure.Patient information and outcome are not available at this time.The optia collection set is not available for return because it was discarded by the customer.

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: review of the customer-provided photographs determined that the filter was assembled to the tubing set incorrectly (backwards), which is a manufacturing error.

Event Description

The customer stated that no donor was connected to the trima device during prime.Therefore, no patient (donor) information is reasonably known.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6115472
• MDR Text Key: 60864480
• Report Number: 1722028-2016-00614
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K153601
• 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: Initial,Followup
• Report Date: 11/18/2016

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: 10/01/2017
• Device Catalogue Number: 10116
• Device Lot Number: 10Y3201
• Other Device ID Number: 05020583101166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• 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