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

Catalog Number 12120

Device Problems Hole In Material (1293); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a spectra optia set was returned for investigation.Upon visual inspection, it was confirmed that a leak from a tear in the tubing line inside the bond socket on the single side of the y-connector component.Upon further inspection excess solvent was observed at the tubing tear location.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that post peripheral blood stem cell (pbsc) collection procedure, the operator heat sealed the stem cell product bag and disconnected as normal.During laboratory processing, the lab technician noted a small hole above the junction of the main inlet and filter tubing lines.The customer stated no product was lost.The customer is alleging a possible bacterial contamination of the product.Patient information is not available at this time.Patient outcome is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: 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.The customer performed an aerobic and anaerobic culture of the product and the product was incubated for 7 days.Test results confirmed no microbial growth of any kind.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: although the customer indicated that one of the possible consequences of the leak was a risk of bacterial contamination of the product, the results from the 7-day bacterial testing concluded that the sterility of the product was not compromised.The customer also indicated that no product was lost as a result of the leak.The cause of this defect was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6716584
• MDR Text Key: 80409010
• Report Number: 1722028-2017-00295
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: 12120
• Device Lot Number: 11Z3309
• Other Device ID Number: 05020583121201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• 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