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

Catalog Number 10120

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported microbial contamination in the collected product after a spectra optia collection procedure.It is unknown at this time if medical intervention was required for this event.Patient information and outcome are not available at this time.The spectra optia collect set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide corrected information.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: per internal documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Manufacturer Narrative

This record is being filed to provide additional information.Additional investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Additional root cause: root cause of the contamination was undetermined.

Event Description

The customer stated terumo bct was not implicated in this incident and declined to provide patient information or outcome.

• 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: 7276541
• MDR Text Key: 100531652
• Report Number: 1722028-2018-00042
• Device Sequence Number: 1
• Product Code: GKT
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2018

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: 08/01/2019
• Device Catalogue Number: 10120
• Device Lot Number: 1708153230
• Other Device ID Number: 05020583101203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 03/12/2018; 03/24/2018; 09/19/2018
• Supplement Dates FDA Received: 03/13/2018; 04/06/2018; 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• 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